Cleared Traditional

VenaTech? LP Vena Cava Filter System and VenaTech? Convertible Vena Cava Filter System

K240578 · B.Braun Medical, Inc. · Cardiovascular
Jul 2024
Decision
152d
Days
Class 2
Risk

About This 510(k) Submission

K240578 is an FDA 510(k) clearance for the VenaTech? LP Vena Cava Filter System and VenaTech? Convertible Vena Cava Filter System, a Filter, Intravascular, Cardiovascular (Class II — Special Controls, product code DTK), submitted by B.Braun Medical, Inc. (Center Valley, US). The FDA issued a Cleared decision on July 31, 2024, 152 days after receiving the submission on March 1, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3375.

Submission Details

510(k) Number K240578 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2024
Decision Date July 31, 2024
Days to Decision 152 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTK — Filter, Intravascular, Cardiovascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3375

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