# Berlin Heart, Inc.

- Location (FDA's records): The Woodlands
- FDA decisions: 1 (2017–2017): 1 original PMA approval
- Product codes: DSQ (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- P160035: EXCOR Pediatric Ventricular Assist Device (Jun 6, 2017)

Source page: https://510kreport.com/company/berlin-heart