K-number	K202916
Device name	Balloon Guiding Catheter
Applicant	Shanghai Heartcare Medical Technology Co., Ltd.
Product code	QJP
Device class	Class II
Decision date	Aug 25, 2021
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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Balloon Guiding Catheter

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