510(k) K121497 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
VENOFER PUMP
| Applicant | Renal Solutions, Inc., Warrendale PA, US |
| Decision | Substantially Equivalent, Aug 17, 2012 |
| Received | May 21, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121497
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2013 | Fresenius Medical Care Holdings, Inc. dba Renal Solutions 2008 MeDS Pump, Venofer(R) Pump
Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.