# Cardiocycle Medical (Suzhou) Co., Ltd.

- Location (FDA's records): Suzhou, Jiangsu, CN
- FDA decisions: 2 (2025–2026): 2 510(k) clearances
- Product codes: DYB (2)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- K251838: Introducer Sheath Set (2025), cited by 1

## Recent decisions
- K254248: Introducer Sheath Set (Apr 23, 2026)
- K251838: Introducer Sheath Set (Oct 21, 2025)

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