K-number	K233820
Device name	Fogarty Arterial Embolectomy Catheter with Gate Valve
Applicant	Edwards Lifesciences
Product code	DXE
Device class	Class II
Decision date	May 22, 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 Arterial Embolectomy Catheter with Gate Valve

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