K142447 is an FDA 510(k) clearance for the PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch. This device is classified as a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II - Special Controls, product code DXZ).
Submitted by Synovis Life Technologies, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 7, 2015, 127 days after receiving the submission on September 2, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3470.
| 510(k) Number | K142447 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2014 |
| Decision Date | January 07, 2015 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXZ - Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3470 |