K043461 is an FDA 510(k) clearance for the CUSTODIOL. This device is classified as a Set, Perfusion, Kidney, Disposable (Class II - Special Controls, product code KDL).
Submitted by Dr. Franz Kohler Chemie GmbH (Brookeville, US). The FDA issued a Cleared decision on February 28, 2005, 75 days after receiving the submission on December 15, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K043461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2004 |
| Decision Date | February 28, 2005 |
| Days to Decision | 75 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 |