Cleared Special

ANGIOJET ULTRA DVX THROMBECTOMY SET

K113428 · Medrad, Inc. · Cardiovascular
Dec 2011
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K113428 is an FDA 510(k) clearance for the ANGIOJET ULTRA DVX THROMBECTOMY SET, a Aspiration Thrombectomy Catheter (Class II — Special Controls, product code QEZ), submitted by Medrad, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 2, 2011, 11 days after receiving the submission on November 21, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K113428 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2011
Decision Date December 02, 2011
Days to Decision 11 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QEZ — Aspiration Thrombectomy Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.

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