Product Code: QEZ FDA class 2 21 CFR 870.5150

Aspiration Thrombectomy Catheter

Cardiovascular

The Aspiration Thrombectomy Catheter is a catheter device used to remove thrombus from the peripheral and/or coronary vasculature through aspiration, restoring blood flow in cases of vascular occlusion. It is classified as FDA Class 2 and is GMP exempt, operating under regulation 870.5150 in the Cardiovascular specialty. The product code is QEZ. It is not an implant and is not life-sustaining.

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510(k)s

FEI Numbers

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Basic Information

Product Code: QEZ
Device Class: FDA class 2
Regulation Number: 870.5150
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✓

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

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

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 92 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253589	Liberant RX Aspiration Catheter	Apr 23, 2026	Substantially Equivalent	Medtronic Interventional Vascular, Inc.
K254208	FLOWRUNNER Aspiration System	Mar 20, 2026	Substantially Equivalent	Expanse Medical, Inc.
K253925	Aventus Thrombectomy System	Jan 15, 2026	Substantially Equivalent	Inquis Medical
K252509	AlphaVac Multipurpose Mechanical Aspiration System F1885	Nov 24, 2025	Substantially Equivalent	AngioDynamics, Inc.
K251312	Vesalio Peripheral System	Oct 24, 2025	Substantially Equivalent	Vesalio, Inc.
K251488	FLOWRUNNER Aspiration System	Jul 14, 2025	Substantially Equivalent	Expanse Medical, Inc.
K243549	JETi Hydrodynamic Thrombectomy System	Apr 04, 2025	Substantially Equivalent	ABBOTT MEDICAL
K250013	VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP)	Mar 24, 2025	Substantially Equivalent	Control Medical Technology, Inc. / Dba Ventiv Scientific
K240397	AlphaVac MMA F1885 System (H787253020)	Apr 01, 2024	Substantially Equivalent	AngioDynamics, Inc.
K232458	JETiHydrodynamic Thrombectomy System	Dec 19, 2023	Substantially Equivalent	ABBOTT MEDICAL
K213388	AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System	Apr 04, 2022	Substantially Equivalent	AngioDynamics, Inc.
K213565	JETi AIO Peripheral Thrombectomy System	Feb 01, 2022	Substantially Equivalent	Walk Vascular, LLC
K212199	ASAP Aspiration Catheter, ASAPLP Aspiration Catheter	Nov 03, 2021	Substantially Equivalent	Merit Medical Systems, Inc.
K213166	Thrombuster II Aspiration Catheter	Oct 26, 2021	Substantially Equivalent	Kaneka Medical America, LLC
K211081	AlphaVac Multipurpose Mechanical Aspiration (MMA) System	Jun 04, 2021	Substantially Equivalent	AngioDynamics, Inc.
K201998	JETi AIO Peripheral Thrombectomy System	Nov 17, 2020	Substantially Equivalent	Walk Vascular, LLC
K200871	Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator	May 04, 2020	Substantially Equivalent	Control Medical Technology
K193197	QuickClear Mechanical Thrombectomy System	Apr 20, 2020	Substantially Equivalent	Volcano Atheromed, Inc.
K192439	JETi Peripheral Thrombectomy System	Dec 09, 2019	Substantially Equivalent	Walk Vascular, LLC
K190619	Aspiron(TM) Aspiration Catheter	Apr 29, 2019	Substantially Equivalent	Meril Life Sciences Private Limited
K183403	JETi 88 Peripheral Thrombectomy System	Apr 17, 2019	Substantially Equivalent	Walk Vascular, LLC
K182232	Octane Mechanical Thrombectomy System	Sep 11, 2018	Substantially Equivalent	Vascular Solutions, Inc.
K173266	Octane aspiration system	Dec 01, 2017	Substantially Equivalent	Vascular Solutions, Inc.
K172000	ClearLumen II Peripheral Thrombectomy System	Oct 24, 2017	Substantially Equivalent	Walk Vascular, LLC
K163051	ClearLumen II Peripheral Thrombectomy System	Feb 21, 2017	Substantially Equivalent	Walk Vascular, LLC
K161786	ClearLumen II Thrombectomy System	Oct 18, 2016	Unknown	Walk Vascular, LLC
K140296	CLEARLUMEN THROMBECTOMY SYSTEM	Dec 02, 2014	Unknown	Walk Vascular, LLC
K131998	ASPIRE RX-LP6 ASPIRATION CATHETER	Nov 26, 2013	Substantially Equivalent	Control Medical Technology, LLC
K132155	Merit ASAPLP Aspiration Catheter	Nov 07, 2013	Substantially Equivalent	Merit Medical Systems, Inc.
K130536	EXPORT ADVANCE ASPIRATION CATHETER	Jul 16, 2013	Substantially Equivalent	Medtronic, Inc.
K123482	REFLOW ASPIRATION CATHETER	Apr 29, 2013	Substantially Equivalent	Volcano Corporation
K120508	CLEARLUMEN THROMBECTOMY SYSTEM	Nov 07, 2012	Substantially Equivalent	Walk Vascular, LLC
K121301	XPRESSWAY RX CATHETER (6F LD-VERISON)	Jul 30, 2012	Substantially Equivalent	Kaneka Pharma America, LLC
K120808	EXPORT XT CATHETER, EXPORT AP CATHETER	Jun 07, 2012	Substantially Equivalent	Medtronic, Inc.
K113363	ANGIOJET SOLENT DISTA THROMBECTOMY SET	Jun 06, 2012	Substantially Equivalent	Medrad, Inc.
K113757	ASPIRE MAX ASPIRATION CATHETER	Feb 22, 2012	Substantially Equivalent	Control Medical Technology, LLC
K112382	TERUMO ASPRIATION CATHETER	Dec 14, 2011	Substantially Equivalent	Terumo Medical Corporation
K113428	ANGIOJET ULTRA DVX THROMBECTOMY SET	Dec 02, 2011	Substantially Equivalent	Medrad, Inc.
K110315	NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE	Oct 20, 2011	Substantially Equivalent	Nexgen Medical Systems, Inc.
K112571	XL EXTRACTION CATHETER	Oct 06, 2011	Substantially Equivalent	Vascular Solutions, Inc.
K111182	ANGIOJET SOLENT OMNI THROMBECTOMY SET	May 24, 2011	Substantially Equivalent	Medrad, Inc.
K100569	MERIT EMBOLECTOMY CATHETER MODEL ASAP100	Mar 11, 2011	Substantially Equivalent	Merit Medical Systems, Inc.
K101354	FETCH 2 ASPIRATION CATHETER MODEL 109400-001	Jan 21, 2011	Substantially Equivalent	Medrad Interventional/Possis
K103405	PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH	Dec 22, 2010	Substantially Equivalent	Vascular Solutions, Inc.
K101839	KANEKA PHARMA AMERICA XPRESS-WAY RX	Oct 22, 2010	Substantially Equivalent	Kaneka Pharma America, LLC
K101406	ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001	Jun 16, 2010	Substantially Equivalent	Medrad Interventional/Possis
K091703	HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131	Oct 14, 2009	Substantially Equivalent	Concentric Medical, Inc.
K091593	ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS	Jun 22, 2009	Substantially Equivalent	Possis Medical, Inc.
K090253	ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001	Apr 08, 2009	Substantially Equivalent	Possis Medical, Inc.
K083784	PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,	Mar 30, 2009	Substantially Equivalent	Vascular Solutions, Inc.
K082382	ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039	Dec 12, 2008	Substantially Equivalent	Possis Medical, Inc.
K081989	MODIFICATION TO FETCH ASPIRATION CATHETER	Sep 26, 2008	Substantially Equivalent	Possis Medical, Inc.
K080806	ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608	Apr 04, 2008	Substantially Equivalent	Possis Medical, Inc.
K073519	QUICKCAT EXTRACTION CATHETER, MODEL 60090-01	Mar 28, 2008	Substantially Equivalent	Kensey Nash Corp.
K073627	FLEXOR EVAC ASPIRATION CATHETER	Mar 04, 2008	Substantially Equivalent	Cook, Inc.
K073441	ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039	Jan 24, 2008	Substantially Equivalent	Possis Medical, Inc.
K072810	PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010	Dec 19, 2007	Substantially Equivalent	Vascular Solutions, Inc.
K072769	ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS	Nov 14, 2007	Substantially Equivalent	Possis Medical, Inc.
K071826	THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910	Nov 09, 2007	Substantially Equivalent	Fox Hollow Technologies
K071727	QXT EXTRACTION CATHETER	Sep 28, 2007	Substantially Equivalent	Vascular Solutions, Inc.
K072269	ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552	Sep 08, 2007	Substantially Equivalent	Possis Medical, Inc.
K071336	ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307	Aug 24, 2007	Substantially Equivalent	Possis Medical, Inc.
K071529	XTRACT CATHETER SYSTEM	Aug 10, 2007	Substantially Equivalent	Lumen Biomedical, Inc.
K071514	ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307	Jul 31, 2007	Substantially Equivalent	Possis Medical, Inc.
K071342	ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039	Jul 31, 2007	Substantially Equivalent	Possis Medical, Inc.
K070403	PRONTO .035 EXTRACTION CATHETER	Jun 13, 2007	Substantially Equivalent	Vascular Solutions, Inc.
K070363	FETCH ASPIRATION CATHETER	May 11, 2007	Substantially Equivalent	Possis Medical, Inc.
K063371	PRONTO V3 EXTRACTION CATHETER, MODEL 5003	Dec 14, 2006	Substantially Equivalent	Vascular Solutions, Inc.
K061951	ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120	Nov 22, 2006	Substantially Equivalent	Possis Medical, Inc.
K062275	RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135	Sep 20, 2006	Unknown	Kerberos Proximal Solutions, Inc.
K062172	FETCH ASPIRATION CATHETER	Sep 20, 2006	Substantially Equivalent	Possis Medical, Inc.
K061958	MEDTRONIC EXPORT XT CATHETER	Sep 05, 2006	Substantially Equivalent	Medtronic Vascular
K053372	LBI CATHETER SYSTEM	Jun 30, 2006	Substantially Equivalent	Lumen Biomedical, Inc.
K060092	QUICKCAT EXTRACTION CATHETER	Mar 09, 2006	Substantially Equivalent	Kensey Nash Corp.
K051880	RIO ASPIRATION CATHETER	Jan 04, 2006	Substantially Equivalent	Boston Scientific Corp
K052256	ANGIOJET XPEEDIOR 120 CATHETER	Nov 10, 2005	Substantially Equivalent	Possis Medical, Inc.
K052232	VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER	Sep 28, 2005	Substantially Equivalent	Vascular Solutions, Inc.
K051917	DIVER C.E. CATHETER	Aug 08, 2005	Substantially Equivalent	Invatec Innovative Technologies, S.R.L.
K051193	VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER	Aug 08, 2005	Substantially Equivalent	Vascular Solutions, Inc.
K050130	KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM	May 13, 2005	Unknown	Kerberos Proximal Solutions, Inc.
K050794	ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER	Apr 28, 2005	Substantially Equivalent	Possis Medical, Inc.
K050139	MODIFICATION TO: EXPORT CATHETER	Mar 22, 2005	Substantially Equivalent	Medtronic Vascular
K050276	DIVER C.E. CATHETER	Mar 07, 2005	Substantially Equivalent	Invatec Innovative Technologies, S.R.L.
K042937	MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER	Jan 31, 2005	Substantially Equivalent	Vascular Solutions, Inc.
K042874	ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX)	Nov 05, 2004	Substantially Equivalent	Possis Medical, Inc.
K040869	EXPORT CATHETER	Jun 01, 2004	Substantially Equivalent	Medtronic Vascular
K040013	ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT	May 18, 2004	Substantially Equivalent	Possis Medical, Inc.
K032763	VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER	Dec 19, 2003	Substantially Equivalent	Vascular Solutions, Inc.
K972610	POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C	Apr 11, 2000	Substantially Equivalent	Possis Medical, Inc.
K990771	6F HYDROLYSER THROMBECTOMY CATHETER	Jun 25, 1999	Substantially Equivalent	Cordis Corp.
K990805	MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER	Mar 15, 1999	Substantially Equivalent	Cordis Corp.
K983534	7F HYDROLYSER THROMBECTOMY CATHETER	Feb 26, 1999	Substantially Equivalent	Cordis Corp.