510(k) K052764 ยท FKQ System, Dialysate Delivery, Central Multiple Patient
DIACAP ULTRA DIALYSIS FLUID FILTER
| Applicant | B. Braun Medizintechnologie GmbH, Melsungen, DE |
| Decision | Substantially Equivalent, Jun 9, 2006 |
| Received | Sep 30, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052764
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2013 | B. Braun Medical, Inc. Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367.
Intended to filter bacteria and endotoxins from dialysis fluid. Terminated |
FKQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.