510(k) K111521 ยท KDN System, Perfusion, Kidney
WAVES
| Applicant | Waters Medical Systems, LLC, Rochester MN, US |
| Decision | Substantially Equivalent, Feb 16, 2012 |
| Received | Jun 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111521
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2022 | Waters Medical Systems LLC WAVES WCM Kidney Cassette Module Terminated |
KDN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.