# Suzhou Hengrui Disheng Medical Co., Ltd.

- Location (FDA's records): Suzhou 215163, CN
- FDA decisions: 3 (2018–2020): 3 510(k) clearances
- Product codes: DQX (1), KRA (1), DQO (1)
- 510(k) review time since 2016: median 220 days, against 106 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 1 (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
- Terumo Medical Corp.: 2 (https://510kreport.com/company/terumo-medical)
- Acme-Monaco Corp.: 1 (https://510kreport.com/company/acme-monaco)

## Firms that cite its devices most
- Suzhou Hengrui Hongyuan Medical Co., Ltd.: 1 (https://510kreport.com/company/suzhou-hengrui-hongyuan-medical)

## Its most-cited devices
- K171665: Microcatheter and guide-wire system (2018), cited by 1

## Recent decisions
- K193653: Hydrophilic Coating Guide Wire (Aug 26, 2020)
- K193647: Superpipe Angiographic Catheter (Jul 29, 2020)
- K171665: Microcatheter and guide-wire system (Jan 11, 2018)

Source page: https://510kreport.com/company/suzhou-hengrui-disheng-medical