510(k) K791899 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
CYCLER SETS MOD. #5C4143, 5C4144, 5C4145
| Applicant | Travenol Laboratories, S.A., Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 13, 1979 |
| Received | Sep 25, 1979 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K791899
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2015 | Baxter Healthcare Corp. Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path Terminated |
KDJ | None listed |
| Oct 17, 2014 | Baxter Healthcare Corp 15 L Cycler Drainage Bag
Product Usage:
For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory. Terminated |
KDJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.