K992209 is an FDA 510(k) clearance for the CUSTODIOL. This device is classified as a System, Perfusion, Kidney (Class II - Special Controls, product code KDN).
Submitted by Dr. Franz Kohler Chemie GmbH (Rockville, US). The FDA issued a Cleared decision on December 10, 1999, 163 days after receiving the submission on June 30, 1999.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K992209 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 1999 |
| Decision Date | December 10, 1999 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KDN - System, Perfusion, Kidney |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5880 |