Cleared Traditional

K130536 - EXPORT ADVANCE ASPIRATION CATHETER

K130536 is an FDA 510(k) clearance for EXPORT ADVANCE ASPIRATION CATHETER, manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K130536 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
137d
Days
Class 2
Risk

K130536 is an FDA 510(k) clearance for the EXPORT ADVANCE ASPIRATION CATHETER. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Medtronic, Inc. (Danvers, US). The FDA issued a Cleared decision on July 16, 2013 after a review of 137 days - within the typical 510(k) review window.

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 - K130536

510(k) Number K130536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2013
Decision Date July 16, 2013
Days to Decision 137 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 125d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 94
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K130536.
CLEARLUMEN THROMBECTOMY SYSTEM
K140296 · Walk Vascular, LLC · Dec 2014
ASPIRE RX-LP6 ASPIRATION CATHETER
K131998 · Control Medical Technology, LLC · Nov 2013
Merit ASAPLP Aspiration Catheter
K132155 · Merit Medical Systems, Inc. · Nov 2013
REFLOW ASPIRATION CATHETER
K123482 · Volcano Corporation · Apr 2013
CLEARLUMEN THROMBECTOMY SYSTEM
K120508 · Walk Vascular, LLC · Nov 2012
XPRESSWAY RX CATHETER (6F LD-VERISON)
K121301 · Kaneka Pharma America, LLC · Jul 2012
K130536 · EXPORT ADVANCE ASPIRATION CATHETER
Download PDF FDA Summary Medtronic, Inc.