K091989 is an FDA 510(k) clearance for the PERFADEX AND PERFADEX WITH THAM. This device is classified as a System, Perfusion, Kidney (Class II - Special Controls, product code KDN).
Submitted by Xvivo Perfusion AB (Gutengurg, SE). The FDA issued a Cleared decision on October 1, 2010, 456 days after receiving the submission on July 2, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K091989 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2009 |
| Decision Date | October 01, 2010 |
| Days to Decision | 456 days |
| Submission Type | Special |
| 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 |