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510(k) K163353

Needle's Eye Snare Retrieval Set - 54cm by Cook Incorporated — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2017
Date Received
November 30, 2016
Clearance Type
Special
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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