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510(k) K233619

Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters by Edwards Lifesciences — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2024
Date Received
November 13, 2023
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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Other clearances for product code DXE

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  • K202049 — Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter (September 7, 2021)
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