# Shanghai Heartcare Medical Technology Co., Ltd.

- Location (FDA's records): Shanghai, CN
- FDA decisions: 3 (2021–2023): 3 510(k) clearances
- Product codes: QJP (3)
- 510(k) review time since 2016: median 330 days, against 184 for FDA's reviews in the same codes and years (1 of 3 faster)
- 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
- Stryker Corp.: 2 (https://510kreport.com/company/stryker)
- Concentric Medical, Inc.: 1 (https://510kreport.com/company/concentric-medical)

## Recent decisions
- K233205: Distal Access Catheter (Dec 22, 2023)
- K202926: Micro Catheter (Feb 10, 2022)
- K202916: Balloon Guiding Catheter (Aug 25, 2021)

Source page: https://510kreport.com/company/shanghai-heartcare-medical-technology