Balloon Guiding Catheter

Catheter, Percutaneous, Neurovasculature

Shanghai Heartcare Medical Technology Co., Ltd

The following data is part of a premarket notification filed by Shanghai Heartcare Medical Technology Co., Ltd with the FDA for Balloon Guiding Catheter.

Pre-market Notification Details

Device IDK202916
510k NumberK202916
Device Name:Balloon Guiding Catheter
ClassificationCatheter, Percutaneous, Neurovasculature
Applicant Shanghai Heartcare Medical Technology Co., Ltd 590 Ruiqing Rd, Building 4, Suite 201, East Zhangjiang High-Tech Park Shanghai,  CN 201201
ContactZongyu Xue
CorrespondentTingting Su
Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai,  CN 200120
Product CodeQJP  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-29
Decision Date2021-08-25

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.