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510(k) K241330

Fogarty Fortis Arterial Embolectomy Catheter by Edwards Lifesciences — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2024
Date Received
May 10, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Embolectomy
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

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