510(k) K053512 ยท FKX System, Peritoneal, Automatic Delivery
HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310
| Applicant | Baxter Healthcare Corp, Mcgaw Park IL, US |
| Decision | Substantially Equivalent, Feb 16, 2006 |
| Received | Dec 16, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053512
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2011 | Baxter Healthcare Renal Div APD Disposable Sets and Extension Sets used with Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
Terminated |
FKX | None listed |
| Mar 1, 2010 | Baxter Healthcare Renal Div Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R, 5C4474D and 5C447DR.
The HomeChoice dialysis system is a personal cycle Terminated |
FKX | None listed |
| Mar 1, 2010 | Baxter Healthcare Renal Div HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, and T5C8300R.
The HomeChoice dialysis system is a personal cycler automated perito Terminated |
FKX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.