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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QEZ Aspiration Thrombectomy Catheter

All 94
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K131998.
ClearLumen II Peripheral Thrombectomy System
K163051 · Walk Vascular, LLC · Feb 2017
ClearLumen II Thrombectomy System
K161786 · Walk Vascular, LLC · Oct 2016
CLEARLUMEN THROMBECTOMY SYSTEM
K140296 · Walk Vascular, LLC · Dec 2014
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