K-number	K143160
Device name	FOXTROT NC PTCA Balloon Catheter
Applicant	Shanghai MicroPort Medical (Group) Co., Ltd.
Product code	LOX
Device class	Class II
Decision date	Mar 5, 2015
Decision	Substantially Equivalent
Regulation	870.5100

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View the full FDA submission: accessdata.fda.gov

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FOXTROT NC PTCA Balloon Catheter

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