Xtract Catheter System

FDA 510(k) K071529 · Lumen Biomedical, Inc.

Substantially Equivalent

510(k) numberK071529

Submission

Device name
Xtract Catheter System
Applicant
Lumen Biomedical, Inc.
Plymouth, MN, US
Received
June 5, 2007
Decision date
August 10, 2007
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QEZ – Aspiration Thrombectomy Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5150
Specialty
Cardiovascular

To remove thrombus from the peripheral and/or coronary vasculature through aspiration.

Other 510(k)s with product code QEZ

510(k)DeviceApplicantDecision
K254035Mayumi™ Thrombectomy SystemQEZ · Traditional MicroVention, Inc., d/b/a Terumo Neuro09/03/2026SE
K261105Powered Aventus Thrombectomy System™QEZ · Traditional Inquis Medical07/27/2026SE
K262030Aventus Thrombectomy SystemQEZ · Special Inquis Medical07/15/2026SE
K253589Liberant™ RX Aspiration CatheterQEZ · Traditional Medtronic Interventional Vascular, Inc.04/23/2026SE
K254208FLOWRUNNER Aspiration SystemQEZ · Special Expanse Medical, Inc.03/20/2026SE
K253925Aventus Thrombectomy SystemQEZ · Traditional Inquis Medical01/15/2026SE
K252509AlphaVac Multipurpose Mechanical Aspiration System F1885QEZ · Traditional AngioDynamics, Inc.11/24/2025SE
K251312Vesalio Peripheral SystemQEZ · Traditional Vesalio, Inc.10/24/2025SE
K251488FLOWRUNNER Aspiration SystemQEZ · Special Expanse Medical, Inc.07/14/2025SE
K243549JETi Hydrodynamic Thrombectomy SystemQEZ · Traditional Abbott Medical04/04/2025SE

More from Abbott Medical

510(k)DeviceDecision
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K082348Fibernet Embolic Protection SystemNTE · Traditional 11/18/2008SE
K080901Lbi Embolectomy SystemQEW · Traditional 10/02/2008SESU
K053372Lbi Catheter SystemQEZ · Traditional 06/30/2006SE

Questions and answers

When was Xtract Catheter System cleared by the FDA?

Xtract Catheter System (K071529) received a 510(k) decision of Substantially Equivalent on August 10, 2007, 66 days after the submission was received.

What is the product code of K071529?

The FDA product code is QEZ – Aspiration Thrombectomy Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.5150.