Cardiovascular Systems, Inc.: FDA clearances and approvals
Cardiovascular Systems, Inc. has 26 FDA 510(k) clearances (first 2007, latest 2022), plus 1 PMA decision, across 4 product codes in 1 review panel. Median 510(k) review time: 48 days. Since 2017 its median was 60 days, against 100 days for all cleared 510(k)s in the same product codes. openFDA lists 17 product recalls by a recalling firm named Cardiovascular Systems, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 29 |
| 2013 | 0 | — |
| 2014 | 1 | 63 |
| 2015 | 2 | 27 |
| 2016 | 0 | — |
| 2017 | 1 | 85 |
| 2018 | 3 | 61 |
| 2019 | 1 | 112 |
| 2020 | 2 | 50 |
| 2021 | 5 | 30 |
| 2022 | 1 | 47 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Cardiovascular Systems, Inc.'s cleared 510(k)s took a median 60 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 100 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | 19 | 19 |
| DQY | Catheter, Percutaneous | 5 | 5 |
| NTE | Temporary Carotid Catheter For Embolic Capture | 2 | 2 |
| MCX | Catheter, Coronary, Atherectomy | 1 | 0 |
Review panels
- Cardiovascular (27)
Most recent Cardiovascular Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220109 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System | MCW | 2022-03-01 | 47 |
| K212725 | ViperCross Support Catheters | DQY | 2021-09-24 | 28 |
| K210586 | Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system | MCW | 2021-09-14 | 200 |
| K211240 | ViperCross Support Catheters | DQY | 2021-08-26 | 122 |
| K211251 | ViperCath XC Peripheral Exchange Catheter | DQY | 2021-05-26 | 30 |
| K210282 | WIRION Embolic Protection System | NTE | 2021-03-03 | 30 |
| K203008 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System | MCW | 2020-11-19 | 49 |
| K200198 | WIRION | NTE | 2020-03-18 | 51 |
| K190634 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System | MCW | 2019-07-02 | 112 |
| K183000 | ViperCath XC Peripheral Exchange Catheter | DQY | 2018-12-29 | 60 |
16 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P130005 | PMA | DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM | 2013-10-21 |
Recalls
17 product recalls in 15 recall events; 1 initiated in the last five years. Most recent: 2021-11-22.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Cardiovascular Systems, Inc. have?
Cardiovascular Systems, Inc. has 26 FDA 510(k) clearances (first 2007, latest 2022), plus 1 PMA decision, across 4 product codes in 1 review panel.
How long does FDA take to clear Cardiovascular Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cardiovascular Systems, Inc.'s cleared 510(k)s is 48 days. Since 2017: 60 days, versus 100 days for all cleared 510(k)s in the same product codes.
What devices does Cardiovascular Systems, Inc. make?
Its most frequent FDA product codes are MCW (Catheter, Peripheral, Atherectomy, 19); DQY (Catheter, Percutaneous, 5); NTE (Temporary Carotid Catheter For Embolic Capture, 2).
Has Cardiovascular Systems, Inc. had device recalls?
openFDA lists 17 product recalls in 15 recall events by a recalling firm whose name matches Cardiovascular Systems, Inc; the most recent began 2021-11-22. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 26 Cardiovascular Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MCW, Cardiovascular Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.