KardiFlex PTCA Balloon Dilatation Catheter

Catheters, Transluminal Coronary Angioplasty, Percutaneous

Medcaptain Life Science Co., Ltd.

The following data is part of a premarket notification filed by Medcaptain Life Science Co., Ltd. with the FDA for Kardiflex Ptca Balloon Dilatation Catheter.

Pre-market Notification Details

Device IDK202619
510k NumberK202619
Device Name:KardiFlex PTCA Balloon Dilatation Catheter
ClassificationCatheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant Medcaptain Life Science Co., Ltd. 601, Building C, Jinweiyuan Industrial Park, Pingshan District Shenzhen,  CN 518118
ContactDavid Xia
CorrespondentDavid Xia
Medcaptain Life Science Co., Ltd. 601, Building C, Jinweiyuan Industrial Park, Pingshan District Shenzhen,  CN 518118
Product CodeLOX  
CFR Regulation Number870.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-10
Decision Date2021-04-29

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