Company ยท US
Cardiovascular Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2022. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (0 in 12 months)
17recalls (0 in 12 months)
14recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 1, 2022 | K220109 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeab Cardiovascular Systems, Inc. | MCW |
| Sep 24, 2021 | K212725 | ViperCross Support Catheters Cardiovascular Systems, Inc. | DQY |
| Sep 14, 2021 | K210586 | Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system Cardiovascular Systems, Inc. | MCW |
| Aug 26, 2021 | K211240 | ViperCross Support Catheters Cardiovascular Systems, Inc. | DQY |
| May 26, 2021 | K211251 | ViperCath XC Peripheral Exchange Catheter Cardiovascular Systems, Inc. | DQY |
| Mar 3, 2021 | K210282 | WIRION Embolic Protection System Cardiovascular Systems, Inc. | NTE |
| Nov 19, 2020 | K203008 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeab Cardiovascular Systems, Inc. | MCW |
| Mar 18, 2020 | K200198 | WIRION Cardiovascular Systems, Inc. | NTE |
| Jul 2, 2019 | K190634 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System Cardiovascular Systems, Inc. | MCW |
| Dec 29, 2018 | K183000 | ViperCath XC Peripheral Exchange Catheter Cardiovascular Systems, Inc. | DQY |
| Dec 13, 2018 | K182397 | Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series Cardiovascular Systems, Inc. | MCW |
| Apr 17, 2018 | K180416 | ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Athere Cardiovascular Systems, Inc. | MCW |
| Jun 9, 2017 | K170792 | Diamondback 360 Peripheral Orbital Atherectomy System Cardiovascular Systems, Inc. | MCW |
| Oct 21, 2015 | K152694 | Diamondback 360 Peripheral Orbital Atherectomy System Cardiovascular Systems, Inc. | MCW |
| Apr 13, 2015 | K150732 | Diamondback 360 Peripheral Orbital Atherectomy System Cardiovascular Systems, Inc. | MCW |
| Feb 28, 2014 | K133999 | DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM Cardiovascular Systems, Inc. | MCW |
| Nov 22, 2013 | K133399 | DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM Cardiovascular Systems Incorporated | MCW |
| Oct 25, 2012 | K122987 | STEALTH 360 ORBITAL PAD SYSTEM Cardiovascular Systems, Inc. | MCW |
| Jul 26, 2011 | K111388 | DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM Cardiovascular Systems, Inc. | MCW |
| Mar 11, 2011 | K110389 | STEALTH 360 ORBITAL PAD SYSTEM Cardiovascular Systems, Inc. | MCW |
| Mar 20, 2009 | K090521 | DIAMONDBACK 360 DBX Cardiovascular Systems, Inc. | MCW |
| Nov 25, 2008 | K083139 | VIPERSPHERE PTA BALLOON CATHETER Cardiovascular Systems, Inc. | DQY |
| Oct 31, 2008 | K082981 | DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT Cardiovascular Systems, Inc. | MCW |
| Nov 9, 2007 | K072748 | MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM Cardiovascular Systems, Inc. | MCW |
| Oct 25, 2007 | K072800 | DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM Cardiovascular Systems, Inc. | MCW |
| Aug 30, 2007 | K071427 | DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS Cardiovascular Systems, Inc. | MCW |
| Aug 22, 2007 | K071350 | DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM Cardiovascular Systems, Inc. | MCW |
| Jan 31, 2005 | K041630 | ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS Cardiovascular Systems Incorporated | MCW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2021 | Cardiovascular Systems Inc WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6 Terminated |
NTE | K210282 |
| Jul 21, 2021 | Cardiovascular Systems Inc STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO Terminated |
MCW | K190634 |
| Jul 21, 2021 | Cardiovascular Systems Inc DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145 Terminated |
MCW | K190634 |
| Apr 13, 2018 | Cardiovascular Systems Inc CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
Product Usage: Usage:
The pump is a component of the OAS that provides the pumping Terminated |
MCX | None listed |
| Sep 14, 2017 | Cardiovascular Systems Inc Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acce Terminated |
MCW | K152694 |
| Sep 14, 2017 | Cardiovascular Systems Inc Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acce Terminated |
MCW | K152694 |
| Apr 14, 2017 | Cardiovascular Systems Inc CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Terminated |
MCX | None listed |
| Apr 10, 2017 | Cardiovascular Systems Inc 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 Periphe Terminated |
MCW | K151260 |
| Mar 3, 2017 | Cardiovascular Systems Inc 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 radio Terminated |
MCW | K151260 |
| Feb 22, 2017 | Cardiovascular Systems Inc 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 patien Terminated |
MCW | K152694 |
| Jun 13, 2016 | Cardiovascular Systems Inc ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR-GW-17. Five (5) guide wire pouches in one (1) guide wire box. For use with CSI Terminated |
MCW | K090521 |
| Mar 20, 2015 | Cardiovascular Systems, Inc. Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125.
The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable can Terminated |
MCX | None listed |
| Aug 14, 2014 | Cardiovascular Systems, Inc. CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003.
The Diamondback 360 Peripheral Orbital Atherectomy System i Terminated |
MCW | K133399 |
| Feb 26, 2014 | Cardiovascular Systems, Inc. CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125
Product Usage: The system is indicated to facilitate stent delivery in patients with coronary ar Terminated |
MCX | K071073 |
| Jul 9, 2012 | Cardiovascular Systems, Inc. CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is Terminated |
MCW | K110389 |
| Sep 10, 2009 | Cardiovascular Systems, Inc. Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70025-02
Expiration 2012-02, Sterilized with Ethylene Oxide , Cardiovascular Systems, Inc., St. Paul, MN USA.
Terminated |
MCW | K071427 K090521 |
| Apr 17, 2009 | Cardiovascular Systems, Inc. Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized with Ethylene Oxide. Manufactured for Cardiovascular Systems, Inc., St. Paul, MN 55112, USA. The ViperWi Terminated |
MCW | K071427 |