Cleared Special

K120808 - EXPORT XT CATHETER, EXPORT AP CATHETER

K120808 is an FDA 510(k) clearance for EXPORT XT CATHETER, manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Special 510(k) pathway after a 83-day FDA review.

K120808 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
83d
Days
Class 2
Risk

K120808 is an FDA 510(k) clearance for the EXPORT XT CATHETER, EXPORT AP 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 June 7, 2012 after a review of 83 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K120808

510(k) Number K120808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2012
Decision Date June 07, 2012
Days to Decision 83 days
Submission Type Special
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
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Modification to existing cleared device.

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 K120808.
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
ANGIOJET SOLENT DISTA THROMBECTOMY SET
K113363 · Medrad, Inc. · Jun 2012
ASPIRE MAX ASPIRATION CATHETER
K113757 · Control Medical Technology, LLC · Feb 2012
TERUMO ASPRIATION CATHETER
K112382 · Terumo Medical Corporation · Dec 2011
K120808 · EXPORT XT CATHETER, EXPORT AP CATHETER
Download PDF FDA Summary Medtronic, Inc.