Cleared Traditional

Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular

K150262 · Volcano Corporation · Cardiovascular
Apr 2015
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K150262 is an FDA 510(k) clearance for the Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular, a Filter, Intravascular, Cardiovascular (Class II — Special Controls, product code DTK), submitted by Volcano Corporation (San Diego, US). The FDA issued a Cleared decision on April 3, 2015, 58 days after receiving the submission on February 4, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3375.

Submission Details

510(k) Number K150262 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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