510(k) K012988 ยท FKX System, Peritoneal, Automatic Delivery
HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469
| Applicant | Baxter Healthcare Corp, Mcgaw Park IL, US |
| Decision | Substantially Equivalent, Dec 5, 2001 |
| Received | Sep 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012988
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 7, 2008 | Baxter Healthcare Renal Div HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, and T5C8300R, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U Terminated |
FKX | None listed |
| Nov 16, 2005 | Baxter Healthcare Renal Div Spanish Patient At-Home Guide for the HomeChoice/HomeChoice Pro Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A. Terminated |
FKX | None listed |
| Jul 19, 2005 | Baxter Healthcare Renal Div HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5 Terminated |
FKX | None listed |
| Jan 15, 2005 | Baxter Healthcare Renal Div HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R Terminated |
FKX | None listed |
| Nov 11, 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, T5C4441, T5C4441 Terminated |
FKX | None listed |
| Nov 11, 2004 | Baxter Healthcare Renal Div HomeChoice PRO and Yume Plus Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, T5C8300 Terminated |
FKX | None listed |
| Jul 20, 2004 | Baxter Healthcare Renal Div HomeChoice PRO and Yume PlusAutomated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, Terminated |
FKX | None listed |
| Feb 21, 2003 | Baxter Healthcare Corp. 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 |
| Feb 21, 2003 | Baxter Healthcare Corp. HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5 Terminated |
FKX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.