The following data is part of a premarket notification filed by Paragonix Technologies with the FDA for Paragonix Sherpapak Pancreas Transport System.
| Device ID | K191440 |
| 510k Number | K191440 |
| Device Name: | Paragonix SherpaPak Pancreas Transport System |
| Classification | System, Perfusion, Kidney |
| Applicant | Paragonix Technologies Suite 408, 639 Granite St. Braintree, MA 02184 |
| Contact | Lisa M. Anderson |
| Correspondent | Leo Basta NorthStar Biomedical Associates 93 Benefit St. Providence, RI 02904 |
| Product Code | KDN |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-30 |
| Decision Date | 2019-12-20 |