510(k) K031676 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
| Applicant | Baxter Healthcare Corp, Mcgaw Park IL, US |
| Decision | Substantially Equivalent, Nov 20, 2003 |
| Received | May 30, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031676
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Baxter Healthcare Corp. Baxter HomeChoice Automated PD Set with Lineo Connector, 4-prong, product codes R5C4479Q (English) and N5C4479Q (dual English/French label); Baxter Healthcare Corporation, Deerfield, IL 60015 USA; 30 Terminated |
KGZ | None listed |
| Jul 20, 2004 | Baxter Healthcare Corp. Baxter Lineo Opticap Disconnect Cap, product codes R5C4599Q (English) and N5C4599Q (dual English/French label); Baxter Healthcare Corporation, Deerfield, IL 60015 USA; 30 units per case Terminated |
KGZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.