Cleared Traditional

ANGIOJET SOLENT DISTA THROMBECTOMY SET

K113363 · Medrad, Inc. · Cardiovascular
Jun 2012
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K113363 is an FDA 510(k) clearance for the ANGIOJET SOLENT DISTA 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 June 6, 2012, 204 days after receiving the submission on November 15, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K113363 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2011
Decision Date June 06, 2012
Days to Decision 204 days
Submission Type Traditional
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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