K-number	K212582
Device name	SpyGlass Discover Balloon Dilation Catheter
Applicant	Boston Scientific Corporation
Product code	GCA
Device class	Class II
Decision date	May 6, 2022
Decision	Substantially Equivalent
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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SpyGlass Discover Balloon Dilation Catheter

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