Aspiration Thrombectomy Catheter

FDA product code QEZ · 94 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.5150
Review panel: CV
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: Yes
Clearance span: 1999-02-26 – 2026-09-03

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

QEZ 2026-09-03

Mayumi™ Thrombectomy System

Applicant MicroVention, Inc., d/b/a Terumo Neuro

K number K254035

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QEZ 2026-07-27

Powered Aventus Thrombectomy System™

Applicant Inquis Medical

K number K261105

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QEZ 2026-07-15

Aventus Thrombectomy System

Applicant Inquis Medical

K number K262030

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QEZ 2026-04-23

Liberant™ RX Aspiration Catheter

Applicant Medtronic Interventional Vascular, Inc.

K number K253589

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QEZ 2026-03-20

FLOWRUNNER Aspiration System

Applicant Expanse Medical, Inc.

K number K254208

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QEZ 2026-01-15

Aventus Thrombectomy System

Applicant Inquis Medical

K number K253925

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QEZ 2025-11-24

AlphaVac Multipurpose Mechanical Aspiration System F1885

Applicant AngioDynamics, Inc.

K number K252509

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QEZ 2025-10-24

Vesalio Peripheral System

Applicant Vesalio, Inc.

K number K251312

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QEZ 2025-07-14

FLOWRUNNER Aspiration System

Applicant Expanse Medical, Inc.

K number K251488

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QEZ 2025-04-04

JETi Hydrodynamic Thrombectomy System

Applicant ABBOTT MEDICAL

K number K243549

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QEZ 2025-03-24

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)

Applicant Control Medical Technology, Inc. / Dba Ventiv Scientific

K number K250013

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QEZ 2024-04-01

AlphaVac MMA F1885 System (H787253020)

Applicant AngioDynamics, Inc.

K number K240397

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QEZ 2023-12-19

JETi™Hydrodynamic Thrombectomy System

Applicant ABBOTT MEDICAL

K number K232458

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QEZ 2022-04-04

AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System

Applicant AngioDynamics, Inc.

K number K213388

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QEZ 2022-02-01

JETi AIO Peripheral Thrombectomy System

Applicant Walk Vascular, LLC

K number K213565

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QEZ 2021-11-03

ASAP Aspiration Catheter, ASAPLP Aspiration Catheter

Applicant Merit Medical Systems, Inc.

K number K212199

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QEZ 2021-10-26

Thrombuster II Aspiration Catheter

Applicant Kaneka Medical America, LLC

K number K213166

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QEZ 2021-06-04

AlphaVac Multipurpose Mechanical Aspiration (MMA) System

Applicant AngioDynamics, Inc.

K number K211081

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QEZ 2020-11-17

JETi AIO Peripheral Thrombectomy System

Applicant Walk Vascular, LLC

K number K201998

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QEZ 2020-05-04

Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator

Applicant Control Medical Technology

K number K200871

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QEZ 2020-04-20

QuickClear Mechanical Thrombectomy System

Applicant Volcano Atheromed, Inc.

K number K193197

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QEZ 2019-12-09

JETi Peripheral Thrombectomy System

Applicant Walk Vascular, LLC

K number K192439

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QEZ 2019-04-29

Aspiron(TM) Aspiration Catheter

Applicant Meril Life Sciences Private Limited

K number K190619

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QEZ 2019-04-17

JETi 88 Peripheral Thrombectomy System

Applicant Walk Vascular, LLC

K number K183403

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QEZ 2018-09-11

Octane Mechanical Thrombectomy System

Applicant Vascular Solutions, Inc.

K number K182232

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QEZ 2017-12-01

Octane aspiration system

Applicant Vascular Solutions, Inc.

K number K173266

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QEZ 2017-10-24

ClearLumen II Peripheral Thrombectomy System

Applicant Walk Vascular, LLC

K number K172000

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QEZ 2017-02-21

ClearLumen II Peripheral Thrombectomy System

Applicant Walk Vascular, LLC

K number K163051

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QEZ 2016-10-18

ClearLumen II Thrombectomy System

Applicant Walk Vascular, LLC

K number K161786

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QEZ 2013-11-26

ASPIRE RX-LP6 ASPIRATION CATHETER

Applicant Control Medical Technology, LLC

K number K131998

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QEZ 2013-11-07

Merit ASAPLP Aspiration Catheter

Applicant Merit Medical Systems, Inc.

K number K132155

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QEZ 2013-07-16

EXPORT ADVANCE ASPIRATION CATHETER

Applicant Medtronic, Inc.

K number K130536

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QEZ 2013-04-29

REFLOW ASPIRATION CATHETER

Applicant Volcano Corporation

K number K123482

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QEZ 2012-11-07

CLEARLUMEN THROMBECTOMY SYSTEM

Applicant Walk Vascular, LLC

K number K120508

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QEZ 2012-07-30

XPRESSWAY RX CATHETER (6F LD-VERISON)

Applicant Kaneka Pharma America, LLC

K number K121301

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QEZ 2012-06-07

EXPORT XT CATHETER, EXPORT AP CATHETER

Applicant Medtronic, Inc.

K number K120808

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QEZ 2012-06-06

ANGIOJET SOLENT DISTA THROMBECTOMY SET

Applicant Medrad, Inc.

K number K113363

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QEZ 2012-02-22

ASPIRE MAX ASPIRATION CATHETER

Applicant Control Medical Technology, LLC

K number K113757

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QEZ 2011-12-14

TERUMO ASPRIATION CATHETER

Applicant Terumo Medical Corporation

K number K112382

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QEZ 2011-12-02

ANGIOJET ULTRA DVX THROMBECTOMY SET

Applicant Medrad, Inc.

K number K113428

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QEZ 2011-10-20

NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE

Applicant Nexgen Medical Systems, Inc.

K number K110315

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QEZ 2011-10-06

XL EXTRACTION CATHETER

Applicant Vascular Solutions, Inc.

K number K112571

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QEZ 2011-05-24

ANGIOJET SOLENT OMNI THROMBECTOMY SET

Applicant Medrad, Inc.

K number K111182

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QEZ 2011-03-11

MERIT EMBOLECTOMY CATHETER MODEL ASAP100

Applicant Merit Medical Systems, Inc.

K number K100569

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QEZ 2011-01-21

FETCH 2 ASPIRATION CATHETER MODEL 109400-001

Applicant Medrad Interventional/Possis

K number K101354

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QEZ 2010-12-22

PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH

Applicant Vascular Solutions, Inc.

K number K103405

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QEZ 2010-10-22

KANEKA PHARMA AMERICA XPRESS-WAY RX

Applicant Kaneka Pharma America, LLC

K number K101839

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QEZ 2010-06-16

ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001

Applicant Medrad Interventional/Possis

K number K101406

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QEZ 2009-10-14

HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131

Applicant Concentric Medical, Inc.

K number K091703

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QEZ 2009-06-22

ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS

Applicant Possis Medical, Inc.

K number K091593

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QEZ 2009-04-08

ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001

Applicant Possis Medical, Inc.

K number K090253

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QEZ 2009-03-30

PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,

Applicant Vascular Solutions, Inc.

K number K083784

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QEZ 2008-12-12

ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039

Applicant Possis Medical, Inc.

K number K082382

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QEZ 2008-09-26

MODIFICATION TO FETCH ASPIRATION CATHETER

Applicant Possis Medical, Inc.

K number K081989

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QEZ 2008-04-04

ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608

Applicant Possis Medical, Inc.

K number K080806

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QEZ 2008-03-28

QUICKCAT EXTRACTION CATHETER, MODEL 60090-01

Applicant Kensey Nash Corp.

K number K073519

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QEZ 2008-03-04

FLEXOR EVAC ASPIRATION CATHETER

Applicant Cook, Inc.

K number K073627

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QEZ 2008-01-24

ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039

Applicant Possis Medical, Inc.

K number K073441

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QEZ 2007-12-19

PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010

Applicant Vascular Solutions, Inc.

K number K072810

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QEZ 2007-11-14

ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS

Applicant Possis Medical, Inc.

K number K072769

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QEZ 2007-11-09

THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910

Applicant Fox Hollow Technologies

K number K071826

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QEZ 2007-09-28

QXT EXTRACTION CATHETER

Applicant Vascular Solutions, Inc.

K number K071727

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QEZ 2007-09-08

ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552

Applicant Possis Medical, Inc.

K number K072269

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QEZ 2007-08-24

ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307

Applicant Possis Medical, Inc.

K number K071336

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QEZ 2007-08-10

XTRACT CATHETER SYSTEM

Applicant Lumen Biomedical, Inc.

K number K071529

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QEZ 2007-07-31

ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307

Applicant Possis Medical, Inc.

K number K071514

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QEZ 2007-07-31

ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039

Applicant Possis Medical, Inc.

K number K071342

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QEZ 2007-06-13

PRONTO .035 EXTRACTION CATHETER

Applicant Vascular Solutions, Inc.

K number K070403

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QEZ 2007-05-11

FETCH ASPIRATION CATHETER

Applicant Possis Medical, Inc.

K number K070363

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QEZ 2006-12-14

PRONTO V3 EXTRACTION CATHETER, MODEL 5003

Applicant Vascular Solutions, Inc.

K number K063371

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QEZ 2006-11-22

ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120

Applicant Possis Medical, Inc.

K number K061951

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QEZ 2006-09-20

RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135

Applicant Kerberos Proximal Solutions, Inc.

K number K062275

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QEZ 2006-09-20

FETCH ASPIRATION CATHETER

Applicant Possis Medical, Inc.

K number K062172

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QEZ 2006-09-05

MEDTRONIC EXPORT XT CATHETER

Applicant Medtronic Vascular

K number K061958

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QEZ 2006-06-30

LBI CATHETER SYSTEM

Applicant Lumen Biomedical, Inc.

K number K053372

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QEZ 2006-03-09

QUICKCAT EXTRACTION CATHETER

Applicant Kensey Nash Corp.

K number K060092

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QEZ 2006-01-04

RIO ASPIRATION CATHETER

Applicant Boston Scientific Corp

K number K051880

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QEZ 2005-11-10

ANGIOJET XPEEDIOR 120 CATHETER

Applicant Possis Medical, Inc.

K number K052256

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QEZ 2005-09-28

VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER

Applicant Vascular Solutions, Inc.

K number K052232

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QEZ 2005-08-08

DIVER C.E. CATHETER

Applicant Invatec Innovative Technologies, S.R.L.

K number K051917

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QEZ 2005-08-08

VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER

Applicant Vascular Solutions, Inc.

K number K051193

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QEZ 2005-05-13

KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM

Applicant Kerberos Proximal Solutions, Inc.

K number K050130

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QEZ 2005-04-28

ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER

Applicant Possis Medical, Inc.

K number K050794

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QEZ 2005-03-22

MODIFICATION TO: EXPORT CATHETER

Applicant Medtronic Vascular

K number K050139

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QEZ 2005-03-07

DIVER C.E. CATHETER

Applicant Invatec Innovative Technologies, S.R.L.

K number K050276

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QEZ 2005-01-31

MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER

Applicant Vascular Solutions, Inc.

K number K042937

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QEZ 2004-11-05

ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX)

Applicant Possis Medical, Inc.

K number K042874

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QEZ 2004-06-01

EXPORT CATHETER

Applicant Medtronic Vascular

K number K040869

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QEZ 2004-05-18

ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT

Applicant Possis Medical, Inc.

K number K040013

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QEZ 2003-12-19

VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER

Applicant Vascular Solutions, Inc.

K number K032763

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QEZ 2000-04-11

POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C

Applicant Possis Medical, Inc.

K number K972610

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QEZ 1999-06-25

6F HYDROLYSER THROMBECTOMY CATHETER

Applicant Cordis Corp.

K number K990771

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QEZ 1999-03-15

MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER

Applicant Cordis Corp.

K number K990805

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QEZ 1999-02-26

7F HYDROLYSER THROMBECTOMY CATHETER

Applicant Cordis Corp.

K number K983534

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