Cardiacassist, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Cardiacassist, Inc.” (first 2000, latest 2024), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 106 days. Since 2017 the median was 106 days, against 119 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 97 |
| 2013 | 0 | — |
| 2014 | 3 | 110 |
| 2015 | 0 | — |
| 2016 | 3 | 105 |
| 2017 | 1 | 155 |
| 2018 | 1 | 24 |
| 2019 | 1 | 195 |
| 2020 | 0 | — |
| 2021 | 1 | 186 |
| 2022 | 1 | 519 |
| 2023 | 2 | 34 |
| 2024 | 1 | 58 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cardiacassist, Inc. took a median 106 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 9 | 9 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 4 | 4 |
| QNR | Blood Pump For Ecmo, Long-Term (> 6 Hours) Use | 3 | 3 |
| DQR | Cannula, Catheter | 1 | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 | 1 |
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | 1 | 1 |
| PZS | Dual Lumen Ecmo Cannula | 1 | 1 |
Review panels
- Cardiovascular (21)
Most recent Cardiacassist, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233736 | LifeSPARC System | QNR | 2024-01-19 | 58 |
| K232480 | ProtekDuo Veno-Venous Cannula Sets | PZS | 2023-10-06 | 51 |
| K232132 | LifeSPARC System | KFM | 2023-08-03 | 16 |
| K211830 | LifeSPARC System | QNR | 2022-11-15 | 519 |
| K202751 | TandemHeart Pump and Escort Controller | QNR | 2021-03-26 | 186 |
| K183623 | LifeSPARC Pump, LifeSPARC Controller | KFM | 2019-07-09 | 195 |
| K181150 | ProtekDuo Mini Veno-Venous Cannula Set | DWF | 2018-05-25 | 24 |
| K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set | DRE | 2017-01-06 | 155 |
| K162214 | Protek Solo 24 Fr Venous Cannula Set | DWF | 2016-11-30 | 114 |
| K160257 | PROTEK Duo 31 Fr. Veno-Venous Cannula Set | DWF | 2016-03-04 | 32 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cardiacassist, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cardiacassist, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Cardiacassist, Inc.” (first 2000, latest 2024), across 8 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cardiacassist, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardiacassist, Inc. is 106 days. Since 2017: 106 days, versus 119 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cardiacassist, Inc.?
The most frequent FDA product codes under this applicant name are DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 9); KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type, 4); QNR (Blood Pump For Ecmo, Long-Term (> 6 Hours) Use, 3).
Next steps
- See all 21 Cardiacassist, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWF, Cardiacassist, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.