The following data is part of a premarket notification filed by Pragonix Technologies with the FDA for Sherpapak Lung Preservation System , Sherpapak Liver Transport System.
| Device ID | K192869 |
| 510k Number | K192869 |
| Device Name: | SherpaPak Lung Preservation System , SherpaPak Liver Transport System |
| Classification | System, Perfusion, Kidney |
| Applicant | Pragonix Technologies Suite 408, 639 Granite Street Braintree, MA 02184 |
| Contact | Lisa Anderson |
| Correspondent | Leo Basta Northstar Biomedical Associates 93 Benefit St Providence, RI 02904 |
| Product Code | KDN |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-07 |
| Decision Date | 2020-01-16 |