Cleared Traditional

ANGIOJET SOLENT DISTA THROMBECTOMY SET (K113363) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K113363 is an FDA 510(k) clearance for the ANGIOJET SOLENT DISTA THROMBECTOMY SET. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Medrad, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 6, 2012 after a review of 204 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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.

View all Medrad, Inc. devices

Submission Details

510(k) Number K113363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 125d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QEZ Aspiration Thrombectomy Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.
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 - QEZ Aspiration Thrombectomy Catheter

All 35
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K113363.
Merit ASAPLP Aspiration Catheter
K132155 · Merit Medical Systems, Inc. · Nov 2013
EXPORT ADVANCE ASPIRATION CATHETER
K130536 · Medtronic, Inc. · Jul 2013
EXPORT XT CATHETER, EXPORT AP CATHETER
K120808 · Medtronic, Inc. · Jun 2012
MERIT EMBOLECTOMY CATHETER MODEL ASAP100
K100569 · Merit Medical Systems, Inc. · Mar 2011
FLEXOR EVAC ASPIRATION CATHETER
K073627 · Cook, Inc. · Mar 2008
MEDTRONIC EXPORT XT CATHETER
K061958 · Medtronic Vascular · Sep 2006