510(k) K152765

VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM by B. Braun Interventional Systems, Inc. — Product Code DTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2016
Date Received
September 24, 2015
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