510(k) K162716 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
bibag
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, May 18, 2017 |
| Received | Sep 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162716
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2021 | Fresenius Medical Care Holdings, Inc. (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE
(2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case
For patients with acute and chronic end stage renal disease going under PD in healthcare or home sett Terminated |
KPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.