FDA 510(k) Applications Submitted by Cardiovascular Systems, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150732 |
03/20/2015 |
Diamondback 360 Peripheral Orbital Atherectomy System |
CARDIOVASCULAR SYSTEMS, INC. |
| K133999 |
12/27/2013 |
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM |
CARDIOVASCULAR SYSTEMS, INC. |
| K071427 |
05/23/2007 |
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS |
CARDIOVASCULAR SYSTEMS, INC. |
| K090521 |
02/26/2009 |
DIAMONDBACK 360 DBX |
CARDIOVASCULAR SYSTEMS, INC. |
| K083139 |
10/23/2008 |
VIPERSPHERE PTA BALLOON CATHETER |
CARDIOVASCULAR SYSTEMS, INC. |
| K082981 |
10/06/2008 |
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT |
CARDIOVASCULAR SYSTEMS, INC. |
| K211240 |
04/26/2021 |
ViperCross Support Catheters |
Cardiovascular Systems, Inc. |
| K211251 |
04/26/2021 |
ViperCath XC Peripheral Exchange Catheter |
Cardiovascular Systems, Inc. |
| K212725 |
08/27/2021 |
ViperCross Support Catheters |
Cardiovascular Systems, Inc. |
| K183000 |
10/30/2018 |
ViperCath XC Peripheral Exchange Catheter |
Cardiovascular Systems, Inc. |
| K072748 |
09/27/2007 |
MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM |
CARDIOVASCULAR SYSTEMS, INC. |
| K072800 |
10/01/2007 |
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM |
CARDIOVASCULAR SYSTEMS, INC. |
| K170792 |
03/16/2017 |
Diamondback 360 Peripheral Orbital Atherectomy System |
Cardiovascular Systems, Inc. |
| K122987 |
09/26/2012 |
STEALTH 360 ORBITAL PAD SYSTEM |
CARDIOVASCULAR SYSTEMS, INC. |
| K110389 |
02/10/2011 |
STEALTH 360 ORBITAL PAD SYSTEM |
CARDIOVASCULAR SYSTEMS, INC. |
| K111388 |
05/17/2011 |
DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM |
CARDIOVASCULAR SYSTEMS, INC. |
| K071350 |
05/14/2007 |
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM |
CARDIOVASCULAR SYSTEMS, INC. |
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