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510(k) K160866

Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit by C.R. Bard, Inc. — Product Code DTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2016
Date Received
March 30, 2016
Clearance Type
Special
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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