K133694 is an FDA 510(k) clearance for the SHERPA PAK TRANSPORTER. This device is classified as a System, Perfusion, Kidney (Class II - Special Controls, product code KDN).
Submitted by Paragonix Technologies, Inc. (Providence, US). The FDA issued a Cleared decision on May 23, 2014, 171 days after receiving the submission on December 3, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K133694 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2013 |
| Decision Date | May 23, 2014 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KDN - System, Perfusion, Kidney |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5880 |