510(k) K240578

VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System by B.Braun Medical, Inc. — Product Code DTK

K240578 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System". The FDA issued a decision of Substantially Equivalent on July 31, 2024. The device falls under product code DTK (Filter, Intravascular, Cardiovascular), a Class II device regulated under 21 CFR 870.3375. B.Braun Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2024
Date Received
March 1, 2024
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