K192869 is an FDA 510(k) clearance for the SherpaPak Lung Preservation System , SherpaPak Liver Transport System. This device is classified as a System, Perfusion, Kidney (Class II - Special Controls, product code KDN).
Submitted by Pragonix Technologies (Braintree, US). The FDA issued a Cleared decision on January 16, 2020, 101 days after receiving the submission on October 7, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K192869 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | October 07, 2019 |
| Decision Date | January 16, 2020 |
| Days to Decision | 101 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 |