K192408 is an FDA 510(k) clearance for the Custodiol HTK Solution. This device is classified as a Set, Perfusion, Kidney, Disposable (Class II - Special Controls, product code KDL).
Submitted by Dr. Franz Kohler Chemie GmbH (Bensheim, DE). The FDA issued a Cleared decision on April 24, 2020, 233 days after receiving the submission on September 4, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K192408 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2019 |
| Decision Date | April 24, 2020 |
| Days to Decision | 233 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KDL - Set, Perfusion, Kidney, Disposable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5880 |