510(k) K002892 ยท FKX System, Peritoneal, Automatic Delivery
FRSENIUS PD IQCARD CYCLER
| Applicant | Fresenius Medical Care North America, Lexington MA, US |
| Decision | Substantially Equivalent, Apr 5, 2001 |
| Received | Sep 15, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002892
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2006 | Fresenius Medical Care North America Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis.
Catalog Number: 050-87028 Terminated |
FKX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.