510(k) K173363 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Cycler Drain Bag Set
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Jan 24, 2018 |
| Received | Oct 26, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173363
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2021 | Fresenius Medical Care Holdings, Inc. The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain Bag Set is used to collect effluent in bags rather Terminated |
KDJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.