# Keystone Heart, Ltd.

- Location (FDA's records): Caesaria, IL
- FDA decisions: 1 (2020–2020): 1 510(k) clearance
- Product codes: DYB (1)
- Predicates its devices cite: 1 (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
- Biocardia, Inc.: 1 (https://510kreport.com/company/biocardia)

## Recent decisions
- K202226: Lim Precision Steerable TS, Steerable Sheath, Dilator (Dec 15, 2020)

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