Embolectomy Catheters

  • Model / Serial
    Model Numbers: Lot Numbers A4402: 1157054, 1163804, 1170473. A4403: 1157060, 1162689, 1166031, 1169109. A4404: 1160223, 1163803, 1166725, 1171181. A4405: 1155214, 1157053, 1161472, 1162967, 1164628, 1168912. A4406: 1155428, 1162945, 1167745, 1170042. A4407: 1154478, 1162866, 1168604. A4408: 1163626. A4F00: 1164152, 1164627, 1168666. A4F01: 1156256, 1160007, 1163628, 1168231. A4F02: 1156522, 1161792, 1170399. A4F03: 1155855, 1157052, 1161793, 1160310, 1159725, 1163215, 1163961, 1167855, 1169632, 1164626, 1165853. A4F04: 1155427, 1160221, 1161791, 1156935, 1171883, 1169729, 1167751, 1165778, 1163384, 1172598. A4F05: 1155854, 1154446, 1156936, 1155230, 1161471, 1160222, 1159414, 1161998, 1163216, 1163962, 1167440, 1166463, 1164625, 1165323, 1168911. A4F06: 1155856, 1154435, 1158624, 1161997, 1164149, 1165777, 1169013. A4F07: 1171170, 1156271, 1167414, 1164151. A4F08: 1168855, 1155648. CE0260ST: 1164307, 1168569. CE0280ST: 1164351. CE0340ST: 1164348. CE0380ST: 1164308, 1164337, 1166033, 1169029, 1166281, 1166032. CE0440ST: 1164336, 1168610. CE0480ST: 1164303, 1164302, 1164335, 1164304, 1166468, 1168605, 1166284, 1166283. CE0580ST: 1164345, 1164346, 1168613. CE0680ST: 1164330, 1166470. CE0780ST: 1164354. CE0340: 1166904. CE0380: 1164344. CE0440: 1164347, 1168609. CE0480: 1164343. CE0580: 1164349. CE0680: 1164353 CE0780: 1169926.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.
  • Product Description
    Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): || Model Numbers & Description: || A4402, 3F-40CM, SYNTEL RT-EMB; || A4403, 3F-80CM, SYNTEL RT-EMB; || A4404, 4F-40CM, SYNTEL RT-EMB; || A4405, 4F-80CM, SYNTEL RT-EMB; || A4406, 5F-80CM, SYNTEL RT-EMB; || A4407, 6F-80CM, SYNTEL RT-EMB; || A4408, 7F-80CM, SYNTEL RT-EMB; || A4F00, 2F-60CM (PREM) SYNTEL CATHETER; || A4F01, 2F-80CM, (PREM) SYNTEL CATHETER; || A4F02, 3F-40CM, (PREM) SYNTEL CATHETER; || A4F03, 3F-80CM, (PREM) SYNTEL CATHETER; || A4F04, 4F-40CM, (PREM) SYNTEL CATHETER; || A4F05, 4F-80CM, (PREM) SYNTEL CATHETER; || A4F06, 5F-80CM, (PREM) SYNTEL CATHETER; || A4F07, 6F-80CM, (PREM) SYNTEL CATHETER; || A4F08, 7F-80CM, (PREM) SYNTEL CATHETER; || CE0260ST, L2F-60CM PREM SYNTEL CATH; || CE0280ST, L2F-80CM PREM SYNTEL CATH; || CE0340ST, 3F-40cm (PREM) SYNTEL CATHETER; || CE0380ST, 3F-80CM PREM SYNTEL CATH; || CE0440ST, 4F-40CM PREM SYNTEL CATH; || CE0480ST, 4F-80CM PREM SYNTEL CATH; || CE0580ST, 5F-80CM PREM SYNTEL CATH; || CE0680ST, 6F-80cm (PREM) SYNTEL CATHETER; || CE0780ST, 7F-80CM PREM SYNTEL CATH; || CE0340, 3F-40cm, SYNTEL RT-EMB; || CE0380, 3F-80cm, SYNTEL RT-EMB; || CE0440, 4F-40cm, SYNTEL RT-EMB; || CE0480, 4F-80cm, SYNTEL RT-EMB; || CE0580, 5F-80cm, SYNTEL RT-EMB; || CE0680, 6F-80cm, SYNTEL RT-EMB; || CE0780, 7F-80cm SYNTEL RT-EMB. || BARD Embolectomy Catheters are indicated for the removal of emboli and thrombi from the peripheral arterial system. These devices consist of a catheter body with a latex-free balloon on the distal end and an inflation hub on the proximal end.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Applied Medical Resources Corp, 22872 Avenida Empresa # 3, Rancho Santa Margarita CA 92688-2650
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

12 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Product Description
    LeMaitre Single Lumen and Over-the-Wire Embolectomy Catheters, LeMaitre Vascular Inc.
  • Manufacturer
  • Model / Serial
  • Product Description
    Lemaitre Vascular: Over-the-Wire Embolectomy Catheters
  • Manufacturer
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