Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardiovascular Systems, Inc. — Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
112 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220109 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMO | Cardiovascular Systems, Inc. | 2022-03-01 | 47 | 0 |
| K212725 | ViperCross Support Catheters | Cardiovascular Systems, Inc. | 2021-09-24 | 28 | 0 |
| K210586 | Diamonback 360 Peripheral Orbital Atherectomy System, Diamon | Cardiovascular Systems, Inc. | 2021-09-14 | 200 | 0 |
| K211240 | ViperCross Support Catheters | Cardiovascular Systems, Inc. | 2021-08-26 | 122 | 0 |
| K211251 | ViperCath XC Peripheral Exchange Catheter | Cardiovascular Systems, Inc. | 2021-05-26 | 30 | 0 |
| K210282 | WIRION Embolic Protection System | Cardiovascular Systems, Inc. | 2021-03-03 | 30 | 1 |
| K203008 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMO | Cardiovascular Systems, Inc. | 2020-11-19 | 49 | 0 |
| K200198 | WIRION | Cardiovascular Systems, Inc. | 2020-03-18 | 51 | 0 |
| K190634 | Diamondback 360 Peripheral Orbital Atherectomy System, Steal | Cardiovascular Systems, Inc. | 2019-07-02 | 112 | 0 |
| K183000 | ViperCath XC Peripheral Exchange Catheter | Cardiovascular Systems, Inc. | 2018-12-29 | 60 | 0 |
| K182397 | Diamondback 360 Peripheral Orbital Atherectomy System Exchan | Cardiovascular Systems, Inc. | 2018-12-13 | 100 | 0 |
| K180416 | ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral | Cardiovascular Systems, Inc. | 2018-04-17 | 61 | 0 |
| K170792 | Diamondback 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2017-06-09 | 85 | 0 |
| K152694 | Diamondback 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2015-10-21 | 30 | 1 |
| K150732 | Diamondback 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2015-04-13 | 24 | 0 |
| K133999 | DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM | Cardiovascular Systems, Inc. | 2014-02-28 | 63 | 0 |
| K122987 | STEALTH 360 ORBITAL PAD SYSTEM | Cardiovascular Systems, Inc. | 2012-10-25 | 29 | 0 |
| K111388 | DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* OR | Cardiovascular Systems, Inc. | 2011-07-26 | 70 | 0 |
| K110389 | STEALTH 360 ORBITAL PAD SYSTEM | Cardiovascular Systems, Inc. | 2011-03-11 | 29 | 1 |
| K090521 | DIAMONDBACK 360 DBX | Cardiovascular Systems, Inc. | 2009-03-20 | 22 | 1 |
| K083139 | VIPERSPHERE PTA BALLOON CATHETER | Cardiovascular Systems, Inc. | 2008-11-25 | 33 | 0 |
| K082981 | DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPER | Cardiovascular Systems, Inc. | 2008-10-31 | 25 | 0 |
| K072748 | MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM | Cardiovascular Systems, Inc. | 2007-11-09 | 43 | 0 |
| K072800 | DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM | Cardiovascular Systems, Inc. | 2007-10-25 | 24 | 0 |
| K071427 | DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATM | Cardiovascular Systems, Inc. | 2007-08-30 | 99 | 2 |
| K071350 | DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM | Cardiovascular Systems, Inc. | 2007-08-22 | 100 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda