510(k) K990953 ยท KPF System, Dialysate Delivery, Semi-Automatic, Peritoneal
RENAL LINK
| Applicant | Baxter Healthcare Corp, Mcgaw Park IL, US |
| Decision | Substantially Equivalent, Jun 18, 1999 |
| Received | Mar 22, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990953
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2006 | Baxter Healthcare Renal Div Baxter Healthcare Corporation, RenalSoft Observational Study v.2.0 - HD Module, PD Module and Medical Record Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illin Terminated |
KPF | None listed |
| May 3, 2006 | Baxter Healthcare Renal Div Baxter Healthcare Corporation, RenalSoft v.1.1 - PD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085 Terminated |
KPF | None listed |
| May 3, 2006 | Baxter Healthcare Renal Div Baxter Healthcare Corporation, Renal Software Suite v.3.1 - HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085 Terminated |
KPF | None listed |
| Jul 20, 2004 | Baxter Healthcare Renal Div Baxter Renal Software Suite (Renal Link and PD Link); Baxter Healthcare Corporation, McGaw Park, Illinois 60085 Terminated |
KPF | None listed |
| Jul 20, 2004 | Baxter Healthcare Renal Div Renalsoft software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085 Terminated |
KPF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.