Medical Device Manufacturer · CN , Suzhou

Cardiocycle Medical(Suzhou) Co., Ltd. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2025

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cardiocycle Medical(Suzhou) Co., Ltd. Cardiovascular ✕

2 devices

1-2 of 2

Cleared Apr 23, 2026

Introducer Sheath Set

Cardiovascular · 115d

Cleared Oct 21, 2025

Introducer Sheath Set

Cardiovascular · 127d