Cleared Traditional

K131998 - ASPIRE RX-LP6 ASPIRATION CATHETER

K131998 is an FDA 510(k) clearance for ASPIRE RX-LP6 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 151-day FDA review.

K131998 · Control Medical Technology, LLC · Cardiovascular device
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Nov 2013
Decision
151d
Days
Class 2
Risk

K131998 is an FDA 510(k) clearance for the ASPIRE RX-LP6 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 November 26, 2013 after a review of 151 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 Control Medical Technology, LLC devices

FDA 510(k) Submission Details - K131998

510(k) Number K131998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2013
Decision Date November 26, 2013
Days to Decision 151 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
26d slower than avg
Panel avg: 125d · This submission: 151d
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 K131998.
JETi 88 Peripheral Thrombectomy System
K183403 · Walk Vascular, LLC · Apr 2019
Octane Mechanical Thrombectomy System
K182232 · Vascular Solutions, Inc. · Sep 2018
Octane aspiration system
K173266 · Vascular Solutions, Inc. · Dec 2017
Merit ASAPLP Aspiration Catheter
K132155 · Merit Medical Systems, Inc. · Nov 2013
EXPORT ADVANCE ASPIRATION CATHETER
K130536 · Medtronic, Inc. · Jul 2013
REFLOW ASPIRATION CATHETER
K123482 · Volcano Corporation · Apr 2013