The following data is part of a premarket notification filed by Helios Cardio Inc. with the FDA for Cardiamend Pericardial And Epicardial Reconstruction Matrix.
| Device ID | K210331 |
| 510k Number | K210331 |
| Device Name: | CardiaMend Pericardial And Epicardial Reconstruction Matrix |
| Classification | Intracardiac Patch Or Pledget, Biologically Derived |
| Applicant | Helios Cardio Inc. 11 Dellbrook Road Weston, MA 02493 |
| Contact | Yiannis Monovoukas |
| Correspondent | Roshana Ahmed Quaras, LLC 2101 Camino Rey Fullerton, CA 92833 |
| Product Code | PSQ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-05 |
| Decision Date | 2021-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850023375056 | K210331 | 000 |
| 00850023375049 | K210331 | 000 |
| 00850023375032 | K210331 | 000 |
| 00850023375025 | K210331 | 000 |
| 00850023375018 | K210331 | 000 |
| 00850023375001 | K210331 | 000 |
| 00850023375087 | K210331 | 000 |