Cleared Traditional

K152765 - VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM

K152765 is an FDA 510(k) clearance for VENATECH CONVERTIBLE VENA CAVA FILTER S..., manufactured by B. Braun Interventional Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DTK cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K152765 · B. Braun Interventional Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
155d
Days
Class 2
Risk

K152765 is an FDA 510(k) clearance for the VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by B. Braun Interventional Systems, Inc. (Bethlehem, US). The FDA issued a Cleared decision on February 26, 2016 after a review of 155 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3375 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K152765

510(k) Number K152765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2015
Decision Date February 26, 2016
Days to Decision 155 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 125d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTK Device Classification - Class 2, Special Controls

Product Code DTK Filter, Intravascular, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTK Filter, Intravascular, Cardiovascular

All 75
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K152765.
Sentry IVC filter
K162875 · Novate Medical , Ltd. · Feb 2017
Gianturco-Roehm Bird’s Nest Vena Cava Filter
K161218 · Cook Incorporated · Jul 2016
Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit
K160866 · C.R. Bard, Inc. · Apr 2016
Option (TM) ELITE Vena Cava Filter 100cm System
K143405 · Rex Medical, L.P. · Apr 2015
Crux Vena Cava Filter System, femoral
K150262 · Volcano Corporation · Apr 2015
Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit
K143208 · C.R. Bard, Inc. · Dec 2014