# Shanghai Microport EP Medtech Co., Ltd.

- Location (FDA's records): Shanghai, CN
- FDA decisions: 4 (2022–2022): 4 510(k) clearances
- Product codes: DYB (2), DRC (1), DRF (1)
- 510(k) review time since 2016: median 267 days, against 143 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 4 (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
- St Jude Medical: 2 (https://510kreport.com/company/st-jude-medical)
- Irvine Biomedical, Inc.: 1 (https://510kreport.com/company/irvine-biomedical)
- Daig Corp.: 1 (https://510kreport.com/company/daig)

## Recent decisions
- K210313: EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter (Dec 30, 2022)
- K212625: PathBuilder Transseptal Needle (Mar 23, 2022)
- K212626: PathBuilder Transseptal Guiding Introducer (Mar 23, 2022)
- K211530: PathBuilder Steerable Introducer (Feb 8, 2022)

Source page: https://510kreport.com/company/shanghai-microport-ep-medtech