K201048 is an FDA 510(k) clearance for the SherpaPak Pediatric Liver Transport System. This device is classified as a System, Perfusion, Kidney (Class II - Special Controls, product code KDN).
Submitted by Paragonix Technologies (Braintree, US). The FDA issued a Cleared decision on July 2, 2020, 72 days after receiving the submission on April 21, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K201048 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 2020 |
| Decision Date | July 02, 2020 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KDN - System, Perfusion, Kidney |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5880 |