K-number	K153729
Device name	8F FlowGate2 Balloon Guide Catheter
Applicant	Concentric Medical
Product code	DQY
Device class	Class II
Decision date	Jan 27, 2016
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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8F FlowGate2 Balloon Guide Catheter

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