The following data is part of a premarket notification filed by Paragonix Technologies, Inc. with the FDA for Sherpa Pak Kidney Transport System.
| Device ID | K143054 |
| 510k Number | K143054 |
| Device Name: | Sherpa Pak Kidney Transport System |
| Classification | System, Perfusion, Kidney |
| Applicant | PARAGONIX TECHNOLOGIES, INC. 639 GRANITE STREET Braintree, MA 02184 |
| Contact | Lisa Anderson |
| Correspondent | Mason Diamond TEXEL FORTIS, LLC 150 LEVINBERG LANE Wayne, NJ 07470 |
| Product Code | KDN |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-23 |
| Decision Date | 2014-11-25 |
| Summary: | summary |