K000881 is an FDA 510(k) clearance for the PERFADEX SOLUTION FOR ORGAN PRESERVATION. This device is classified as a System And Accessories, Isolated Heart, Transport And Preservation (Class II - Special Controls, product code MSB).
Submitted by Vitrolife Sweden AB (Ringoes, US). The FDA issued a Cleared decision on March 8, 2001, 353 days after receiving the submission on March 20, 2000.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K000881 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2000 |
| Decision Date | March 08, 2001 |
| Days to Decision | 353 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 |