# Helios Cardio, Inc.

- Location (FDA's records): Weston, MA
- FDA decisions: 1 (2021–2021): 1 510(k) clearance
- Product codes: PSQ (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cormatrix Cardiovascular, Inc.: 2 (https://510kreport.com/company/cormatrix-cardiovascular)

## Recent decisions
- K210331: CardiaMend Pericardial and Epicardial Reconstruction Matrix (Dec 21, 2021)

Source page: https://510kreport.com/company/helios-cardio