K123326 is an FDA 510(k) clearance for the SHERPA PAK CARDIAC TRANSPORT SYSTEM. This device is classified as a System And Accessories, Isolated Heart, Transport And Preservation (Class II - Special Controls, product code MSB).
Submitted by Paragonix Technologies, Inc. (Providence, US). The FDA issued a Cleared decision on February 6, 2013, 103 days after receiving the submission on October 26, 2012.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K123326 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2012 |
| Decision Date | February 06, 2013 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MSB - System And Accessories, Isolated Heart, Transport And Preservation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5880 |