Cleared Special

K071529 - XTRACT CATHETER SYSTEM

K071529 is an FDA 510(k) clearance for XTRACT CATHETER SYSTEM, manufactured by Lumen Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Special 510(k) pathway after a 66-day FDA review.

K071529 · Lumen Biomedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
66d
Days
Class 2
Risk

K071529 is an FDA 510(k) clearance for the XTRACT CATHETER SYSTEM. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Lumen Biomedical, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 10, 2007 after a review of 66 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 - K071529

510(k) Number K071529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2007
Decision Date August 10, 2007
Days to Decision 66 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
59d faster than avg
Panel avg: 125d · This submission: 66d
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 K071529.
QXT EXTRACTION CATHETER
K071727 · Vascular Solutions, Inc. · Sep 2007
ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552
K072269 · Possis Medical, Inc. · Sep 2007
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307
K071336 · Possis Medical, Inc. · Aug 2007
ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039
K071342 · Possis Medical, Inc. · Jul 2007
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307
K071514 · Possis Medical, Inc. · Jul 2007
PRONTO .035 EXTRACTION CATHETER
K070403 · Vascular Solutions, Inc. · Jun 2007
K071529 · XTRACT CATHETER SYSTEM
Download PDF FDA Summary Lumen Biomedical, Inc.