510(k) K012774 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
JOSTRA ARTERIAL PERFUSION CANNULAE
| Applicant | Jostra AG, Oxford PA, US |
| Decision | Substantially Equivalent, Nov 16, 2001 |
| Received | Aug 20, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012774
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 14, 2018 | Maquet Cardiopulmonary Ag Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass Terminated |
DWF | None listed |
| May 14, 2018 | Maquet Cardiopulmonary Ag Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass Terminated |
DWF | None listed |
| May 14, 2018 | Maquet Cardiopulmonary Ag Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002267, Article Number A24-7107. For use in cardiopulmonary bypass Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.