510(k) K895631 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Jan 29, 1990 |
| Received | Sep 19, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895631
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2015 | Baxter Healthcare Corp. MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis. Completed |
KDI | None listed |
| Jul 17, 2014 | Baxter Healthcare Corp. Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Terminated |
KDI | None listed |
| Jun 30, 2014 | Baxter Healthcare Corp. Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis. Terminated |
KDI | None listed |
| Jun 21, 2013 | Baxter Healthcare Corp. Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.
Intended to isolate the Easy-Lock connector of the solution transfer set. Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.