Cardiovascular Systems Inc

4 devices in the database

  • Model / Serial
    Lot Number 92254 92693 106281 106282 106283 106284 106285 106286 106287 106288 106290 106543 118121 118223 121782 123165 123489 123547 123808 123878 124088 124289 124925 124927 124989 125310 125347 125362 126696 126797 126925 127026 127155 127221 127348 127614 127742 127834 128001 128027 128132 128179 128326 129266 129303 132418 132839 132966 133231 133429 133759 133880 134057 134318 134534 134966 135199 135372 135791 135941 136729 136881 136883 137221 137361 137657 137862 138218 138462 138614 139049 139295 139621 140470 140606 142474 142596 142604 142909 143084 143213 143277 143335 143419 143553 143556 143806 144066 144276 144496 145536 145946 146051 146199 146337 146401 146518 146843 146999 147508 147530 148129 148169 148400 148712 148897 149117 149268 149527 150273 150285 150774 150831 151196 151228 151440 151635 151867 151994 152092 152178 152321 152389 152522 152889 153280 153678 154011 154434 154682 154948 155270 156044 156340 156683 156713 157869 158004 152178 152321 158124 158234 158370 158422 158558 158617 160312 160352 160995 161165 161241 161328 161466 161603 161679 161774 161892 162318 162344 162384 162402 162421 162439 163493 163600 164048 164293 164561 164873 165087 165353 165811 165971 166068 166226 166653 166863 166907 167024 167115 167146 168006 168048 168052 168087 168093 168143 168173 168589 169662 170066 170315 170350 170385 171566 171679 171915 172145 172379 172490 172491 172755 172859 172871 173226 173486 173783 174051 174434 174621 174637 174659 175087 175167 176653 177218 177359 177385 177625 178212 178237 178742 179133 179287 179558 179602 179649 179955 180225 180360 180463 180629 181317 181320 181556 181586 182441 182442 182494 182495 182537 182539 183099 183101 183150 183400 186393 186683 186820 186881 187241 187242 187398 101182a 101534A 102274a 103369a 104183B 105371a 106346A 106346b 108335A 110016A 111785a 111785b 114148a 114964a 49267-4A 50805A 50805a 50891A 50949A 50949B 51191A 51344A 51345A 51498A 51498B 51570A 51571a 51725A 52006A 52089A 52090B 52253A 52258A 52258b 52347A 52377A 52378A 52666a 52890a 52907A 52908a 52915B 52915C 52963A 52968a 53675B 53689A 53802A 53802B 54321A 54321B 54321C 54814A 54826A 54827A 54828A 54829A 54996A 55065B 55097A 55097B 55097C 55100A 55133A 55198A 55286a 55507a 55973A 56195A 56195B 56313A 56313B 56417A 56421A 56638A 56638B 56697A 56732A 56733A 56810A 56810B 56811A 56951A 56952A 57095a 57096A 57098B 57215A 57216A 57223A 57238A 57281A 57342a 57407A 57454A 57610A 57691A 57692a 57864A 57866a 57930A 57974A 57992B 58052A 58054A 58054B 58141A 58158A 58262A 58309A 58354a 58710A 58781A 58783a 62814A 62856A 62856B 62908A 63010A 63054A 63054B 63322B 63374A 63374B 63374C 63430A 63430B 63430c 64895A 66052A 66138A 66221a 66503a 66571A 67046a 67174A 67391A 67465A 67465b 67818a 67930a 67930b 68200A 68200b 68200C 68346a 68686A 68686b 68686c 69174A 69320A 69709A 69709B 69912A 70295A 70669A 70758A 70821A 71061a 71125A 71343A 71720A 71720B 71817A 71817B 71934A 72291A 72291B 72725a 72901a 73378A 73987A 74737A 75702a 76877a 77104a 77180A 77339A 77647a 77782A 77961A 78249A 78758A 80916A 81073A 81595A 81595b 81873a 82183B 85417A 86237A 86640A 87049A 92285a 97352A 98263A 99375A 99562a
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    US: AK, AL, AR, AZ. , CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, AUSTRIA, GERMANY, JAPAN, SWITZERLAND.
  • Product Description
    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
  • Model / Serial
    Lot #: 175069, 175070, 176255
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, SC, SD, TN, TX, and WA
  • Product Description
    ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14. || Product Usage: || The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
  • Model / Serial
    Lot 156032
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution in the states of AR, AZ, CO, FL, GA, HI, IN, KS, KY, LA, MS. NC, NM, RI, TX, VA
  • Product Description
    ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide. || The guide wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper positioning of the device crown within peripheral arteries and provides a center of rotation for the device drive shaft. The guide wire torquer is a small, plastic accessory, packaged with the guide wire, and provides a gripping surface for manipulating the guide wire, if desired.
  • Model / Serial
    Lot: 171686, Expiration: 2018-09-30
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to LA, MS, SC, TX
  • Product Description
    DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 || Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation of plaque in the arteries of the leg or foot and reduces blood flow that may lead to pain, tissue loss, and eventual foot amputation, leg amputation or death. The system treats a broad range of plaque types in the lower limbs || The DIAMONDBACK 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty. || The Stealth 360 Orbital PAD System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

5 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Cardiovascular Systems Inc, 1225 Old Hwy 8 NW, Saint Paul MN 55112-6416
  • Manufacturer Parent Company (2017)
  • Source
    USFDA