The following data is part of a premarket notification filed by Paragonix Technologies, Inc. with the FDA for Sherpa Pak Cardiac Transport System.
| Device ID | K123326 |
| 510k Number | K123326 |
| Device Name: | SHERPA PAK CARDIAC TRANSPORT SYSTEM |
| Classification | System And Accessories, Isolated Heart, Transport And Preservation |
| Applicant | PARAGONIX TECHNOLOGIES, INC. 755 WESTMINISTER STREET UNIT 120 Providence, MA 02903 |
| Contact | Leo Basta |
| Correspondent | Leo Basta PARAGONIX TECHNOLOGIES, INC. 755 WESTMINISTER STREET UNIT 120 Providence, MA 02903 |
| Product Code | MSB |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-26 |
| Decision Date | 2013-02-06 |
| Summary: | summary |