Cleared Traditional

K113757 - ASPIRE MAX ASPIRATION CATHETER

K113757 is an FDA 510(k) clearance for ASPIRE MAX ASPIRATION CATHETER, manufactured by Control Medical Technology, LLC. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K113757 · Control Medical Technology, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
63d
Days
Class 2
Risk

K113757 is an FDA 510(k) clearance for the ASPIRE MAX ASPIRATION CATHETER. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Control Medical Technology, LLC (Park City, US). The FDA issued a Cleared decision on February 22, 2012 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Control Medical Technology, LLC devices

FDA 510(k) Submission Details - K113757

510(k) Number K113757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2011
Decision Date February 22, 2012
Days to Decision 63 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

QEZ Device Classification - Class 2, Special Controls

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 72
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K113757.
REFLOW ASPIRATION CATHETER
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K120808 · Medtronic, Inc. · Jun 2012
ANGIOJET SOLENT DISTA THROMBECTOMY SET
K113363 · Medrad, Inc. · Jun 2012
ANGIOJET ULTRA DVX THROMBECTOMY SET
K113428 · Medrad, Inc. · Dec 2011
XL EXTRACTION CATHETER
K112571 · Vascular Solutions, Inc. · Oct 2011
ANGIOJET SOLENT OMNI THROMBECTOMY SET
K111182 · Medrad, Inc. · May 2011