K-number	K241330
Device name	Fogarty Fortis Arterial Embolectomy Catheter
Applicant	Edwards Lifesciences
Product code	DXE
Device class	Class II
Decision date	Jul 2, 2024
Decision	Substantially Equivalent
Regulation	870.5150

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Source

View the full FDA submission: accessdata.fda.gov

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Fogarty Fortis Arterial Embolectomy Catheter

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