510(k) K020693 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101
| Applicant | Embol-X, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Sep 5, 2002 |
| Received | Mar 4, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020693
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 15, 2004 | Edwards Lifesciences Research Medical Inc EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''. Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.