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Cardiovascular Systems Inc

9 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr recall (Z-0394-2022)Cardiovascular Systems Inc2021-12-21
ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01, recall (Z-1877-2017)Cardiovascular Systems Inc2017-04-10
DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherect recall (Z-1230-2017)Cardiovascular Systems Inc2017-02-22
Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is recall (Z-1290-2015)Cardiovascular Systems, Inc.2015-03-20
CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, M recall (Z-2155-2014)Cardiovascular Systems, Inc.2014-08-14
CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Numb recall (Z-1095-2014)Cardiovascular Systems, Inc.2014-02-26
CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Numbe recall (Z-1959-2012)Cardiovascular Systems, Inc.2012-07-09
Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70 recall (Z-2028-2009)Cardiovascular Systems, Inc.2009-09-10
Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized recall (Z-1250-2009)Cardiovascular Systems, Inc.2009-04-17

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Every clearance here is in the API, with alerts when new ones post.