# Respicardia

- Location (FDA's records): Minnetonka, MN
- FDA decisions: 2 (2013–2017): 1 510(k) clearance and 1 original PMA approval
- Product codes: DQY (1), PSR (1)
- Predicates its devices cite: 3 (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
- Merit Medical Systems, Inc.: 3 (https://510kreport.com/company/merit-medical-systems)

## Recent decisions
- P160039: remede® System (Oct 6, 2017)
- K130378: Respiguide Delivery System (Oct 17, 2013)

Source page: https://510kreport.com/company/respicardia
