Medical Device Manufacturer · CN , Beijing

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

7 submissions · 6 cleared · Since 2011

Recent clearances: Type I, Type II, Type III, Type IV

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
K172331 · DYB
Cardiovascular · 212d
Cleared Oct 05, 2017
Shoocin Introducer Kit
K172099 · DYB
Cardiovascular · 86d
Cleared Jan 21, 2015
ULTRASKIN HYDROPHILIC GUIDE WIRE
K141707 · DQX
Cardiovascular · 211d
Cleared Oct 23, 2014
Vasc Band hemostat
K142359 · DXC
Cardiovascular · 59d
Cleared Feb 03, 2014
SHOOCIN INTRODUCER KIT
K123475 · DYB
Cardiovascular · 447d
Cleared Aug 13, 2013
HOPER PTCA BALLOON CATHETER
K123473 · LOX
Cardiovascular · 273d
Cleared Sep 27, 2011
RADIAL ARTERY COMPRESSION TOURNIQUET
K111837 · DXC
Cardiovascular · 90d
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