The following data is part of a premarket notification filed by Paragonix Technologies, Inc. with the FDA for Sherpapak Cardiac Transport System And Sherpapak Kidney Transport System.
| Device ID | K180194 |
| 510k Number | K180194 |
| Device Name: | SherpaPak Cardiac Transport System And SherpaPak Kidney Transport System |
| Classification | System And Accessories, Isolated Heart, Transport And Preservation |
| Applicant | Paragonix Technologies, Inc. d/o Vaughn & Asociates 639 Granite Street Braintree, MA 02118 4 |
| Contact | Leo Basta |
| Correspondent | Leo Basta Northstar Biomedical Associates 93 Benefit Street Providence, RI 02904 |
| Product Code | MSB |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-24 |
| Decision Date | 2018-03-30 |
| Summary: | summary |