Cleared Special

K061958 - MEDTRONIC EXPORT XT CATHETER

K061958 is the FDA 510(k) clearance for MEDTRONIC EXPORT XT CATHETER by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code QEZ) cleared through the Special 510(k) pathway after a 56-day FDA review.

K061958 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
56d
Days
Class 2
Risk

K061958 is an FDA 510(k) clearance for the MEDTRONIC EXPORT XT CATHETER. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Medtronic Vascular (Danvers, US). The FDA issued a Cleared decision on September 5, 2006 after a review of 56 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.

View all Medtronic Vascular devices

Submission Details

510(k) Number K061958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2006
Decision Date September 05, 2006
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 50
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K061958.
QXT EXTRACTION CATHETER
K071727 · Vascular Solutions, Inc. · Sep 2007
PRONTO .035 EXTRACTION CATHETER
K070403 · Vascular Solutions, Inc. · Jun 2007
PRONTO V3 EXTRACTION CATHETER, MODEL 5003
K063371 · Vascular Solutions, Inc. · Dec 2006
RIO ASPIRATION CATHETER
K051880 · Boston Scientific Corp · Jan 2006
VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER
K052232 · Vascular Solutions, Inc. · Sep 2005
VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER
K051193 · Vascular Solutions, Inc. · Aug 2005