510(k) K080034 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
THREE STAGE VENOUS RETURN CANNULA, MODEL 816460
| Applicant | Terumo Cardiovascular Systems Corp., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Jun 17, 2008 |
| Received | Jan 7, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080034
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2014 | Terumo Cardiovascular Systems Corporation Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare.
Product Usage:
Venous Return Cannula is indicated for venous drainage during card Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.