K-number	K231629
Device name	091 Balloon Guide Catheter
Applicant	Eosolutions, Corp.
Product code	DQY
Device class	Class II
Decision date	Oct 31, 2023
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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091 Balloon Guide Catheter

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