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510(k) K193379

Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe by Edwards Lifesciences, LLC — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2020
Date Received
December 5, 2019
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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