510(k) K160257 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
PROTEK Duo 31 Fr. Veno-Venous Cannula Set
| Applicant | Cardiacassist, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent, Mar 4, 2016 |
| Received | Feb 1, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160257
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2021 | Cardiac Assist, Inc SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass.
Including the following components:
a) 31 Fr ProtekDuo Veno-Venous Cannula Set
b) LifeSPARC Pump
c) 14Fr to 26 Fr Dil Open, Classified |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.