K172660 is an FDA 510(k) clearance for the Duravess bovine pericardial vascular patch. This device is classified as a Intracardiac Patch Or Pledget, Biologically Derived (Class II - Special Controls, product code PSQ).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on November 17, 2017, 73 days after receiving the submission on September 5, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3470. To Repair Defects, To Be Used For Patch Grafting, To Repair Tissue, And To Buttress Sutures In The Heart And Vasculature..
| 510(k) Number | K172660 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2017 |
| Decision Date | November 17, 2017 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PSQ — Intracardiac Patch Or Pledget, Biologically Derived |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3470 |
| Definition | To Repair Defects, To Be Used For Patch Grafting, To Repair Tissue, And To Buttress Sutures In The Heart And Vasculature. |