510(k) K952631 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
BRAUN HEMODIALYSIS BLOOD CIRCUITS
| Applicant | B.Braun Medical, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Apr 30, 1996 |
| Received | Jun 8, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952631
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2008 | B. Braun Medical, Inc. Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210513. The product is shipped 4 units per shipping carton. Hemodialysis kit, B. Braun Medical, Inc., Allentown, PA 181 Terminated |
FJK | None listed |
| May 7, 2008 | B. Braun Medical, Inc. Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210517. The product is shipped 4 units per shipping carton. Hemodialysis kit, B. Braun Medical, Inc., Allentown, PA 18 Terminated |
FJK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.