Medical Device Manufacturer · CN , Shenzhen

Medcaptain Life Science Co., Ltd. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2021

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Medcaptain Life Science Co., Ltd. Cardiovascular ✕

2 devices

1-2 of 2

Cleared May 06, 2021

KardiFlex NC Coronary Dilatation Catheter

Cardiovascular · 240d

Cleared Apr 29, 2021

KardiFlex PTCA Balloon Dilatation Catheter

Cardiovascular · 231d