K210331 is an FDA 510(k) clearance for the CardiaMend Pericardial and Epicardial Reconstruction Matrix. This device is classified as a Intracardiac Patch Or Pledget, Biologically Derived (Class II - Special Controls, product code PSQ).
Submitted by Helios Cardio, Inc. (Weston, US). The FDA issued a Cleared decision on December 21, 2021, 319 days after receiving the submission on February 5, 2021.
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 | K210331 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2021 |
| Decision Date | December 21, 2021 |
| Days to Decision | 319 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. |