510(k) K002857 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
ELS CANNULA (KIT), MODEL M1210-88,M1510-88
| Applicant | Jostra AG, Newark DE, US |
| Decision | Substantially Equivalent, Oct 5, 2000 |
| Received | Sep 13, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002857
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2013 | Maquet Cardiovascular Us Sales, Llc Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants. Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.