K190882 is an FDA 510(k) clearance for the XenoSure Biologic Patch. This device is classified as a Intracardiac Patch Or Pledget, Biologically Derived (Class II - Special Controls, product code PSQ).
Submitted by Lemaitre Vascular (Burlington, US). The FDA issued a Cleared decision on February 13, 2020, 315 days after receiving the submission on April 4, 2019.
This device falls under the General & Plastic Surgery 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 | K190882 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2019 |
| Decision Date | February 13, 2020 |
| Days to Decision | 315 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| 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. |