K032794 is an FDA 510(k) clearance for the CUSTODIOL. This device is classified as a System And Accessories, Isolated Heart, Transport And Preservation (Class II - Special Controls, product code MSB).
Submitted by Dr. Franz Kohler Chemie GmbH (Brookeville, US). The FDA issued a Cleared decision on April 5, 2004, 210 days after receiving the submission on September 8, 2003.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K032794 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2003 |
| Decision Date | April 05, 2004 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MSB - System And Accessories, Isolated Heart, Transport And Preservation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5880 |