CardiaMend Pericardial and Epicardial Reconstruction Matrix— 510(k) K210331
Substantially EquivalentHelios Cardio, Inc.
FDA 510(k) clearance K210331 for CardiaMend Pericardial and Epicardial Reconstruction Matrix, Substantially Equivalent on 2021-12-21. Applicant: Helios Cardio, Inc..
Clearance details
- Applicant
- Helios Cardio, Inc.
- Product code
- Code PSQ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Weston, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.