Aspire RX-LP6 Aspiration Catheter

FDA 510(k) K131998 · Control Medical Technology, LLC

Substantially Equivalent

510(k) numberK131998

Submission

Device name
Aspire RX-LP6 Aspiration Catheter
Applicant
Control Medical Technology, LLC
Park City, UT, US
Received
June 28, 2013
Decision date
November 26, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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
K200629Aspire Mechanical Aspirator GFMF · Special 05/29/2020SE
K200871Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical AspiratorQEZ · Special 05/04/2020SE
K113757Aspire Max Aspiration CatheterQEZ · Traditional 02/22/2012SE

Questions and answers

When was Aspire RX-LP6 Aspiration Catheter cleared by the FDA?

Aspire RX-LP6 Aspiration Catheter (K131998) received a 510(k) decision of Substantially Equivalent on November 26, 2013, 151 days after the submission was received.

What is the product code of K131998?

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