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510(k) K210734

Endovascular Dilator and Sets by Cook Incorporated — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2021
Date Received
March 11, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, For Percutaneous Catheterization
Device Class
Class II
Regulation Number
870.1310
Review Panel
CV
Submission Type

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