510(k) K090878 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING)
| Applicant | Terumo Cardiovascular Systems Corp., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Apr 3, 2009 |
| Received | Mar 31, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090878
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2014 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare,
Product Usage:
Venous Return Cannula is indicated for venous drainage dur Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.