Medical Device Manufacturer · CN , Beijing

Lepu Medical Technology (Beijing) Co., Ltd. - FDA 510(k) Cleared Devi...

7 submissions · 6 cleared · Since 2011

7

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Lepu Medical Technology (Beijing) Co., Ltd. Cardiovascular ✕

7 devices

1-7 of 7

Cleared Mar 02, 2018

Type I, Type II, Type III, Type IV

Cardiovascular · 212d

Cleared Oct 05, 2017

Shoocin Introducer Kit

Cardiovascular · 86d

Cleared Jan 21, 2015

ULTRASKIN HYDROPHILIC GUIDE WIRE

Cardiovascular · 211d

Cleared Oct 23, 2014

Vasc Band hemostat

Cardiovascular · 59d

Cleared Feb 03, 2014

SHOOCIN INTRODUCER KIT

Cardiovascular · 447d

Cleared Aug 13, 2013

HOPER PTCA BALLOON CATHETER

Cardiovascular · 273d

Cleared Sep 27, 2011

RADIAL ARTERY COMPRESSION TOURNIQUET

Cardiovascular · 90d