The following data is part of a premarket notification filed by Paragonix Technologies with the FDA for Paragonix Sherpapak Cardiac Transport System.
| Device ID | K182735 |
| 510k Number | K182735 |
| Device Name: | Paragonix SherpaPak Cardiac Transport System |
| Classification | System And Accessories, Isolated Heart, Transport And Preservation |
| Applicant | Paragonix Technologies 639 Granite Street #408 Braintree, MA 02184 |
| Contact | Lisa M. Anderson |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-28 |
| Decision Date | 2018-10-19 |