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510(k) K161218

Gianturco-Roehm Bird’s Nest Vena Cava Filter by Cook Incorporated — Product Code DTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2016
Date Received
April 29, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Intravascular, Cardiovascular
Device Class
Class II
Regulation Number
870.3375
Review Panel
CV
Submission Type

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