Cleared Traditional

K150262 - Crux Vena Cava Filter System, femoral

Also marketed or referenced as:
Crux Vena Cava Filter System, jugular

K150262 is an FDA 510(k) clearance for Crux Vena Cava Filter System, manufactured by Volcano Corporation. The device is a Class 2 Cardiovascular device with product code DTK cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K150262 · Volcano Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
58d
Days
Class 2
Risk

K150262 is an FDA 510(k) clearance for the Crux Vena Cava Filter System, femoral. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by Volcano Corporation (San Diego, US). The FDA issued a Cleared decision on April 3, 2015 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K150262

510(k) Number K150262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2015
Decision Date April 03, 2015
Days to Decision 58 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
67d faster than avg
Panel avg: 125d · This submission: 58d
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 79
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K150262.
Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit
K160866 · C.R. Bard, Inc. · Apr 2016
VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM
K152765 · B. Braun Interventional Systems, Inc. · Feb 2016
Option (TM) ELITE Vena Cava Filter 100cm System
K143405 · Rex Medical, L.P. · Apr 2015
Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit
K143208 · C.R. Bard, Inc. · Dec 2014
OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER
K140286 · Cordis, A Johnson & Johnson Co. · Mar 2014
OPTION ELITE VENA CAVA FILTER SYSTEM
K133243 · Rex Medical, L.P. · Dec 2013
K150262 · Crux Vena Cava Filter System, femoral
Download PDF FDA Summary Volcano Corporation