Atlas FDA

Cardiovascular Systems, Inc.

26 FDA 510(k) clearances · Manufacturer

Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System (K220109)Cardiovascular Systems, Inc.2022-03-01
ViperCross Support Catheters (K212725)Cardiovascular Systems, Inc.2021-09-24
Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system (K210586)Cardiovascular Systems, Inc.2021-09-14
ViperCross Support Catheters (K211240)Cardiovascular Systems, Inc.2021-08-26
ViperCath XC Peripheral Exchange Catheter (K211251)Cardiovascular Systems, Inc.2021-05-26
WIRION Embolic Protection System (K210282)Cardiovascular Systems, Inc.2021-03-03
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System (K203008)Cardiovascular Systems, Inc.2020-11-19
WIRION (K200198)Cardiovascular Systems, Inc.2020-03-18
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System (K190634)Cardiovascular Systems, Inc.2019-07-02
ViperCath XC Peripheral Exchange Catheter (K183000)Cardiovascular Systems, Inc.2018-12-29
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series (K182397)Cardiovascular Systems, Inc.2018-12-13
ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System (K180416)Cardiovascular Systems, Inc.2018-04-17
Diamondback 360 Peripheral Orbital Atherectomy System (K170792)Cardiovascular Systems, Inc.2017-06-09
Diamondback 360 Peripheral Orbital Atherectomy System (K152694)Cardiovascular Systems, Inc.2015-10-21
Diamondback 360 Peripheral Orbital Atherectomy System (K150732)Cardiovascular Systems, Inc.2015-04-13
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (K133999)Cardiovascular Systems, Inc.2014-02-28
STEALTH 360 ORBITAL PAD SYSTEM (K122987)Cardiovascular Systems, Inc.2012-10-25
DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM (K111388)Cardiovascular Systems, Inc.2011-07-26
STEALTH 360 ORBITAL PAD SYSTEM (K110389)Cardiovascular Systems, Inc.2011-03-11
DIAMONDBACK 360 DBX (K090521)Cardiovascular Systems, Inc.2009-03-20
VIPERSPHERE PTA BALLOON CATHETER (K083139)Cardiovascular Systems, Inc.2008-11-25
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT (K082981)Cardiovascular Systems, Inc.2008-10-31
MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM (K072748)Cardiovascular Systems, Inc.2007-11-09
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM (K072800)Cardiovascular Systems, Inc.2007-10-25
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS (K071427)Cardiovascular Systems, Inc.2007-08-30
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM (K071350)Cardiovascular Systems, Inc.2007-08-22

Track Cardiovascular Systems, Inc. automatically

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