510(k) K944866 ยท KDL Set, Perfusion, Kidney, Disposable
VIASPAN (BELZER UW - CSS)
| Applicant | The Dupont Merck Pharmaceutical Co., Wilmington DE, US |
| Decision | Substantially Equivalent, Apr 22, 1996 |
| Received | Oct 3, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944866
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2012 | Teva Pharmaceuticals USA, Inc. ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed Pharmaceuticals label (10 x 1000mL bags).
Disposable kidney perfusion set. Terminated |
KDL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.