Abbott Vascular

What is this?

Description

14 devices in the database

  • Model / Serial
    Lot Number: 0070961
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including AL, CA, CT, DC, FL, GA, IA, IL, IN, MA, ME, MI, MN, MO, OH, OK PA, TX, VA, and WI
  • Product Description
    RX ACCULINK Carotid Stent System 7-10 X 40mm, Part Number: 1011344-40, Lot Number: 0072061 || The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. (1) Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND (2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.
  • Model / Serial
    Lot Number: 0072061
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including AL, CA, CT, DC, FL, GA, IA, IL, IN, MA, ME, MI, MN, MO, OH, OK PA, TX, VA, and WI
  • Product Description
    RX ACCULINK Carotid Stent System 10 X 20mm, Part Number: 1011342-20, Lot Number: 0072061 || The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. (1) Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND (2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.
  • Model / Serial
    Lot Number: 0071361
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including AL, CA, CT, DC, FL, GA, IA, IL, IN, MA, ME, MI, MN, MO, OH, OK PA, TX, VA, and WI
  • Product Description
    RX ACCULINK Carotid Stent System 9 X 20mm, Part Number: 1011341-20, Lot Number: 0071361 || The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. (1) Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND (2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.
  • Model / Serial
    U.S. Lot #: 737538, 737576, 738162, 738486, 738641, 739286, 739518, 739837, 740078, 740090, 740306, 740310, 740575, 740579, 740583, 740591, 740599, 740824, 740828, 740832, 740836, 742024, 742028, 742032, 742036, 742040, 742234, 742238, 742246, 742250, 742509, 742513, 742517, 742521, 742759, 742767, 742775, 742783, 742932, 742936, 742940, 742944, 742948, 742952, 742956, 743092, 743096, 743100, 743194, 743197, 743203, 743206, 743209, 743212, 743215, 743469, 743473, 743477, 743481, 743489, 743565, 743862, 743866, 743870, 743874, 743878, 743882, 743886, 744277, 744285, 744289, 744293, 744297, 744301, 744361, 744419, 744423, 744427, 744431, 744435, 744525, 744618, 744622, 744626, 744630, 744634, 744874, 744878, 744882, 744886, 744890, 744894, 745237, 745245, 745249, 745253, 745538, 745542, 745547, 745731, 745735, 745743, 745747, 745949, 745953, 745957, 745961, 745965, 745969, 746237, 746249, 746253, 746257, 746358, 746362, 746366, 746370, 746565, 746569, 746767, 746783, 746968, 746972, 746976, 747149, 747153, 747161, 747165, 747326, 747347, 747351, 747545, 747549, 747565, 747736, 747740, 747744, 747753, 747757, 747765, 747899, 747907, 748103, 748107, 748111, 748115, 748119, 748127, 748309, 748317, 748321, 748437, 748473, 748608, 749158, 749174, 749312, 749320, 749324, 749328, 749332, 749336, 749340, 749537, 749582, 749800, 749933, 749937, 749980, 749988, 750000, 750008, 750130, 750134, 750150, 750154, 750315, 750319, 750324, 750332, 750336, 750340, 750344, 750487, 750491, 750495, 750500, 750504, 750508, 750829, 750833, 750845, 751169, 751326, 751334, 751338, 751342, 751529, 751533, 751889, 751897, 752089, 752097, 752349, 752369, 752429, 752441, 752453, 752461, 752619, 752623, 752627, 752639, 752643, 752777, 752781, 752785, 752794, 752798, 752802, 753142, 753150, 753153, 753169, 753173, 753277, 753281, 753285, 753289, 753297, 753481, 753485, 753608, 753726, 753730, 753734, 754054, 754062, 754066, 754070, 754074, 754187, 754191, 754599, 754603, 754607, 754619, 754623, 754783, 754787, 754791, 754795, 754799, 754803, 754948, 755240, 755244, 755431, 755443, 755606, 755610, 755614, 755792, 755818, 755826, 755834, 755838, 755842, 756002, 756006, 756010, 756156, 756160, 756164, 756169, 756173, 756177, 756441, 756445, 756465, 756469, 756473, 756477, 756481, 756662, 756666, 756670, 756694, 756698, 756702, 756868, 756872, 756876, 756880, 756884, 757077, 757081, 757085, 757089, 757260, 757264, 757268, 757280, 757296, 757440, 757456, 757472, 757476, 757676, 757680, 757684, 757692, 757696, 757704, 757708, 757712, 757716, 757890, 757894, 757898, 757902, 757914, 757918, 757922, 757926, 758067, 758071, 758075, 758079, 758083, 758087, 758091, 758095, 758288, 758296, 758300, 758304, 758312, 758316, 758324, 758500, 758504, 758508 ,758528, 758875, 758879, 758883, 758887, 758891, 758895, 758899, 758903, 759090, 759094, 759102, 759106, 759110, 759114, 759118, 759122, 759270, 759278, 759282, 759429, 759433, 759437, 759441, 759445, 759449, 759453, 759457, 759662, 759666, 759670, 759674, 759678, 759682, 759686, 759840, 759848, 759852, 759856, 759864, 759868, 759872, 759876, 759880, 760039, 760047, 760051, 760059, 760063, 760067, 760071, 760075, 760079, 760208, 760212, 760216, 760220, 760224, 760228, 760232, 760236, 760240, 760248, 760458, 760462, 760466, 760470, 760482, 760689, 760693, 760697, 760701, 760705, 760854, 760858, 760862, 760866, 760878, 760882, 761215, 761231, 761243, 761486, 761495, 761499, 761503, 761507, 761511, 761523, 761735, 761739, 761743, 761747, 761752, 761764, 761768, 761932, 761936, 761940, 761944, 761948, 761952, 761960, 762070, 762109, 762113, 762121, 762129, 762133, 762137, 762292, 762296, 762300, 762304, 762308, 762312, 762316, 762320, 762324, 762466, 762474, 762478, 762482, 762486, 762512, 762671, 762679, 762683, 762687, 762691, 762699, 762841, 762845, 762853, 762857, 762861, 762869, 763000, 763008, 763012, 763016, 763024, 763143, 763151, 763155, 763163, 763167, 763171, 763191, 763195, 763203, 763211, 763215, 763220, 763224, 763238, 763242, 763246, 763258, 763262, 763266, 763270, 763306, 763310, 763314, 763318, 763322, 763326, 763330, 763492, 763496, 763499, 763502, 763506, 763610, 763614, 763618, 763626, 763630, 763634, 763638, 763642, 763646, 763770, 763774, 763778, 763782, 763786, 763794, 763798, 763802, 763806, 763894, 763898, 763902, 763906, 763910, 763914, 763918, 763922, 763926, 764075, 764084, 764088, 764130, 764134, 764142, 764146, 764150, 764154, 764158, 764162, 764169, 764193, 764205, 764221, 764229, 764237, 764241, 764269, 764367, 764375, 764379, 764383, 764387, 764395, 764399, 764460, 764476, 764484, 764488, 764492, 764496, 764500, 764508, 764512, 764615, 764619, 764663, 764667, 764680, 764684, 764852, 764869, 765196, 765200, 765226, 765358, 765366, 765370, 765374, 765404, 765431, 765435, 765682, 765906, 766065, 766230, 766246, 766250, 766254, 766262, 766488, 766683, 766691, 766695, 766855, 766859, 766871, 767020, 767024, 767028, 767032, 767040, 767184, 767192, 767212, 767216, 767349, 767361, 767582, 767586, 767728, 767752, 767756, 767760, 767971, 767983, 767987, 768122, 768243, 768248, 768252, 768256, 768260, 768264, 768362, 768378, 768382, 768469, 768473, 768477, 768481, 768485, 768489, 768501, 768505, 768594, 768659, 768667, 768671, 769031, 769035, 769178, 769190, 769346, 769350, 769517, 769521, 769525, 769529, 769541, 769549, 769553, 769861, 769865, 769965, 769973, 769977, 769981, 770130, 770142, 770146, 770154, 770162, 770333, 770345, 770349, 770679, 770699, 770703, 770707, 771042, 771046, 771050, 771208, 771212, 771216, 771220, 771437, 771441, 771667, 771679, 771960, 771968, 772157, 772415, 772560, 772806, 773110, 773114, 774228, 774698.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide(US) Distribution and Puerto Rico.
  • Product Description
    Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
  • Model / Serial
    Lot Number: 1081061, 1082561, 1091361, 1080561, 1081761, 1090261, 1091561, 1100461, 1080361, 1081661, 1090161, 1090861, 1092361, 1080861, 1082661, 1100761, 1081761, 1092861, 1082461, 1081161, 1082261, 1083061, 1081961, 1093061.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, China, Germany, Spain, France, United Kingdom, Italy, Pakistan, Poland, Russia, Slovakia, Taiwan, and South Africa.
  • Product Description
    Brand Name: RX Accunet Embolic Protection System || Common Name: RX Accunet EPS. || Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. || The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.
9 more

47 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    PMDAJ
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NZMMDSA
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    FSSH
42 more