510(k) K923065 ยท FKX System, Peritoneal, Automatic Delivery
BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Mar 4, 1994 |
| Received | Jun 25, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923065
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2012 | Baxter Healthcare Renal Div Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufactured for Baxter He Terminated |
FKX | None listed |
| Mar 7, 2008 | Baxter Healthcare Renal Div Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, and T5C4441R, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U Terminated |
FKX | None listed |
| Jul 19, 2005 | Baxter Healthcare Renal Div HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, Terminated |
FKX | None listed |
| Jul 20, 2004 | Baxter Healthcare Renal Div HomeChoice and Yume Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, Terminated |
FKX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.