Medical Device Manufacturer · US , Saint Paul , MN

Cardiovascular Systems, Inc.

26 submissions · 26 cleared · Since 2007
26
Total
26
Cleared
0
Denied

Cardiovascular Systems, Inc. — FDA 510(k) Submissions

Cardiovascular Systems, Inc. has submitted 26 FDA 510(k) premarket notifications since 2007, of which 26 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Peripheral, Atherectomy, Catheter, Percutaneous, Temporary Carotid Catheter For Embolic Capture . Use the specialty filter in the sidebar to narrow results.

26 devices
1–25 of 26
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
K220109 · MCW Catheter, Peripheral,... · Cardiovascular
Mar 2022 47d
ViperCross Support Catheters
K212725 · DQY Catheter, Percutaneous · Cardiovascular
Sep 2021 28d
Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system
K210586 · MCW Catheter, Peripheral,... · Cardiovascular
Sep 2021 200d
ViperCross Support Catheters
K211240 · DQY Catheter, Percutaneous · Cardiovascular
Aug 2021 122d
ViperCath XC Peripheral Exchange Catheter
K211251 · DQY Catheter, Percutaneous · Cardiovascular
May 2021 30d
WIRION Embolic Protection System
K210282 · NTE Temporary Carotid... · Cardiovascular
Mar 2021 30d
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
K203008 · MCW Catheter, Peripheral,... · Cardiovascular
Nov 2020 49d
WIRION
K200198 · NTE Temporary Carotid... · Cardiovascular
Mar 2020 51d
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System
K190634 · MCW Catheter, Peripheral,... · Cardiovascular
Jul 2019 112d
ViperCath XC Peripheral Exchange Catheter
K183000 · DQY Catheter, Percutaneous · Cardiovascular
Dec 2018 60d
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
K182397 · MCW Catheter, Peripheral,... · Cardiovascular
Dec 2018 100d
ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System
K180416 · MCW Catheter, Peripheral,... · Cardiovascular
Apr 2018 61d
Diamondback 360 Peripheral Orbital Atherectomy System
K170792 · MCW Catheter, Peripheral,... · Cardiovascular
Jun 2017 85d
Diamondback 360 Peripheral Orbital Atherectomy System
K152694 · MCW Catheter, Peripheral,... · Cardiovascular
Oct 2015 30d
Diamondback 360 Peripheral Orbital Atherectomy System
K150732 · MCW Catheter, Peripheral,... · Cardiovascular
Apr 2015 24d
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
K133999 · MCW Catheter, Peripheral,... · Cardiovascular
Feb 2014 63d
STEALTH 360 ORBITAL PAD SYSTEM
K122987 · MCW Catheter, Peripheral,... · Cardiovascular
Oct 2012 29d
DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM
K111388 · MCW Catheter, Peripheral,... · Cardiovascular
Jul 2011 70d
STEALTH 360 ORBITAL PAD SYSTEM
K110389 · MCW Catheter, Peripheral,... · Cardiovascular
Mar 2011 29d
DIAMONDBACK 360 DBX
K090521 · MCW Catheter, Peripheral,... · Cardiovascular
Mar 2009 22d
VIPERSPHERE PTA BALLOON CATHETER
K083139 · DQY Catheter, Percutaneous · Cardiovascular
Nov 2008 33d
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT
K082981 · MCW Catheter, Peripheral,... · Cardiovascular
Oct 2008 25d
MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
K072748 · MCW Catheter, Peripheral,... · Cardiovascular
Nov 2007 43d
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
K072800 · MCW Catheter, Peripheral,... · Cardiovascular
Oct 2007 24d
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
K071427 · MCW Catheter, Peripheral,... · Cardiovascular
Aug 2007 99d
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