K-number	K211610
Device name	Fogarty Occlusion Catheter
Applicant	Edwards Lifesciences, LLC
Product code	MJN
Device class	Class II
Decision date	Feb 14, 2022
Decision	Substantially Equivalent
Regulation	870.4450

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Source

View the full FDA submission: accessdata.fda.gov

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Fogarty Occlusion Catheter

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