KDL Angiography Catheter

Catheter, Intravascular, Diagnostic

Shanghai Kindly Medical Instruments Co., Ltd.

The following data is part of a premarket notification filed by Shanghai Kindly Medical Instruments Co., Ltd. with the FDA for Kdl Angiography Catheter.

Pre-market Notification Details

Device IDK201929
510k NumberK201929
Device Name:KDL Angiography Catheter
ClassificationCatheter, Intravascular, Diagnostic
Applicant Shanghai Kindly Medical Instruments Co., Ltd. No. 925 Jinyuan Yi Road Shanghai,  CN 201803
ContactXu Jianhai
CorrespondentJeffery Hui
Shanghai Kindly Medical Instruments Co., Ltd. No. 925, Jinyuan Yi Road Shanghai,  CN 201803
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-10
Decision Date2021-05-14

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