510(k) K192408 ยท KDL Set, Perfusion, Kidney, Disposable
Custodiol HTK Solution
| Applicant | Dr. Franz Kohler Chemie GmbH, Bensheim, DE |
| Decision | Substantially Equivalent, Apr 24, 2020 |
| Received | Sep 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192408
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2024 | Dr Franz Koehler Chemie Gmbh Custodiol HTK Solution, 500ml bottle. 10 per carton. Open, Classified |
KDL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.