K170826 is an FDA 510(k) clearance for the Perfadex Plus. This device is classified as a System, Perfusion, Kidney (Class II - Special Controls, product code KDN).
Submitted by Xvivo Perfusion AB (Sloane, SE). The FDA issued a Cleared decision on June 22, 2018, 459 days after receiving the submission on March 20, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K170826 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2017 |
| Decision Date | June 22, 2018 |
| Days to Decision | 459 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 |