Cleared Special

MODIFICATION TO: EXPORT CATHETER (K050139) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K050139 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
60d
Days
Class 2
Risk

K050139 is an FDA 510(k) clearance for the MODIFICATION TO: EXPORT 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 March 22, 2005 after a review of 60 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 K050139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2005
Decision Date March 22, 2005
Days to Decision 60 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
65d faster than avg
Panel avg: 125d · This submission: 60d
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 34
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K050139.
FLEXOR EVAC ASPIRATION CATHETER
K073627 · Cook, Inc. · Mar 2008
MEDTRONIC EXPORT XT CATHETER
K061958 · Medtronic Vascular · Sep 2006
RIO ASPIRATION CATHETER
K051880 · Boston Scientific Corp · Jan 2006
EXPORT CATHETER
K040869 · Medtronic Vascular · Jun 2004
6F HYDROLYSER THROMBECTOMY CATHETER
K990771 · Cordis Corp. · Jun 1999
MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER
K990805 · Cordis Corp. · Mar 1999