K191440 is an FDA 510(k) clearance for the Paragonix SherpaPak Pancreas Transport System, a System, Perfusion, Kidney (Class II — Special Controls, product code KDN), submitted by Paragonix Technologies (Braintree, US). The FDA issued a Cleared decision on December 20, 2019, 204 days after receiving the submission on May 30, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K191440 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 30, 2019 |
| Decision Date | December 20, 2019 |
| Days to Decision | 204 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 |