510(k) K152765

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

K152765 is an FDA 510(k) premarket notification submitted by B. Braun Interventional Systems, Inc. for the device "VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM". The FDA issued a decision of Substantially Equivalent on February 26, 2016. The device falls under product code DTK (Filter, Intravascular, Cardiovascular), a Class II device regulated under 21 CFR 870.3375. B. Braun Interventional Systems, Inc. has at least 2 other 510(k) clearances on record.

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