K-number	K203840
Device name	BOSS 8F Balloon Guide Catheter
Applicant	Marblehead Medical, LLC
Product code	QJP
Device class	Class II
Decision date	Jan 28, 2021
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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BOSS 8F Balloon Guide Catheter

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