K-number	K223189
Device name	Firefighter NC Pro PTCA Balloon Catheter
Applicant	Shanghai MicroPort Medical (Group) Co., Ltd.
Product code	LOX
Device class	Class II
Decision date	Jul 21, 2023
Decision	Substantially Equivalent
Regulation	870.5100

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Source

View the full FDA submission: accessdata.fda.gov

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Firefighter NC Pro PTCA Balloon Catheter

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Firefighter NC Pro PTCA Balloon Catheter