Atlas FDA

QEZ

94 FDA 510(k) clearances · Product code

90 daysmedian time to decision
177 days90th percentile
94clearances measured

FDA profile

Official device name
Aspiration Thrombectomy Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5150
Medical specialty
Cardiovascular
Flags
GMP exempt
FDA definition
To remove thrombus from the peripheral and/or coronary vasculature through aspiration.
Adverse events (MAUDE)
2022: 18 · 2024: 17 · 2025: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Powered Aventus Thrombectomy System™ (K261105)Inquis Medical2026-07-27
Aventus Thrombectomy System (K262030)Inquis Medical2026-07-15
Liberant™ RX Aspiration Catheter (K253589)Medtronic Interventional Vascular, Inc.2026-04-23
FLOWRUNNER Aspiration System (K254208)Expanse Medical, Inc.2026-03-20
Aventus Thrombectomy System (K253925)Inquis Medical2026-01-15
AlphaVac Multipurpose Mechanical Aspiration System F1885 (K252509)AngioDynamics, Inc.2025-11-24
Vesalio Peripheral System (K251312)Vesalio, Inc.2025-10-24
FLOWRUNNER Aspiration System (K251488)Expanse Medical, Inc.2025-07-14
JETi Hydrodynamic Thrombectomy System (K243549)ABBOTT MEDICAL2025-04-04
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) (K250013)Control Medical Technology, Inc. / Dba Ventiv Scientific2025-03-24
AlphaVac MMA F1885 System (H787253020) (K240397)AngioDynamics, Inc.2024-04-01
JETi™Hydrodynamic Thrombectomy System (K232458)ABBOTT MEDICAL2023-12-19
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System (K213388)AngioDynamics, Inc.2022-04-04
JETi AIO Peripheral Thrombectomy System (K213565)Walk Vascular, LLC2022-02-01
ASAP Aspiration Catheter, ASAPLP Aspiration Catheter (K212199)Merit Medical Systems, Inc.2021-11-03
Thrombuster II Aspiration Catheter (K213166)Kaneka Medical America, LLC2021-10-26
AlphaVac Multipurpose Mechanical Aspiration (MMA) System (K211081)AngioDynamics, Inc.2021-06-04
JETi AIO Peripheral Thrombectomy System (K201998)Walk Vascular, LLC2020-11-17
Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator (K200871)Control Medical Technology2020-05-04
QuickClear Mechanical Thrombectomy System (K193197)Volcano Atheromed, Inc.2020-04-20
JETi Peripheral Thrombectomy System (K192439)Walk Vascular, LLC2019-12-09
Aspiron(TM) Aspiration Catheter (K190619)Meril Life Sciences Private Limited2019-04-29
JETi 88 Peripheral Thrombectomy System (K183403)Walk Vascular, LLC2019-04-17
Octane Mechanical Thrombectomy System (K182232)Vascular Solutions, Inc.2018-09-11
Octane aspiration system (K173266)Vascular Solutions, Inc.2017-12-01
ClearLumen II Peripheral Thrombectomy System (K172000)Walk Vascular, LLC2017-10-24
ClearLumen II Peripheral Thrombectomy System (K163051)Walk Vascular, LLC2017-02-21
ClearLumen II Thrombectomy System (K161786)Walk Vascular, LLC2016-10-18
CLEARLUMEN THROMBECTOMY SYSTEM (K140296)Walk Vascular, LLC2014-12-02
ASPIRE RX-LP6 ASPIRATION CATHETER (K131998)Control Medical Technology, LLC2013-11-26
Merit ASAPLP Aspiration Catheter (K132155)Merit Medical Systems, Inc.2013-11-07
EXPORT ADVANCE ASPIRATION CATHETER (K130536)Medtronic, Inc.2013-07-16
REFLOW ASPIRATION CATHETER (K123482)Volcano Corporation2013-04-29
CLEARLUMEN THROMBECTOMY SYSTEM (K120508)Walk Vascular, LLC2012-11-07
XPRESSWAY RX CATHETER (6F LD-VERISON) (K121301)Kaneka Pharma America, LLC2012-07-30
EXPORT XT CATHETER, EXPORT AP CATHETER (K120808)Medtronic, Inc.2012-06-07
ANGIOJET SOLENT DISTA THROMBECTOMY SET (K113363)Medrad, Inc.2012-06-06
ASPIRE MAX ASPIRATION CATHETER (K113757)Control Medical Technology, LLC2012-02-22
TERUMO ASPRIATION CATHETER (K112382)Terumo Medical Corporation2011-12-14
ANGIOJET ULTRA DVX THROMBECTOMY SET (K113428)Medrad, Inc.2011-12-02
NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE (K110315)Nexgen Medical Systems, Inc.2011-10-20
XL EXTRACTION CATHETER (K112571)Vascular Solutions, Inc.2011-10-06
ANGIOJET SOLENT OMNI THROMBECTOMY SET (K111182)Medrad, Inc.2011-05-24
MERIT EMBOLECTOMY CATHETER MODEL ASAP100 (K100569)Merit Medical Systems, Inc.2011-03-11
FETCH 2 ASPIRATION CATHETER MODEL 109400-001 (K101354)Medrad Interventional/Possis2011-01-21
PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH (K103405)Vascular Solutions, Inc.2010-12-22
KANEKA PHARMA AMERICA XPRESS-WAY RX (K101839)Kaneka Pharma America, LLC2010-10-22
ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001 (K101406)Medrad Interventional/Possis2010-06-16
HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131 (K091703)Concentric Medical, Inc.2009-10-14
ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS (K091593)Possis Medical, Inc.2009-06-22
ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001 (K090253)Possis Medical, Inc.2009-04-08
PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER, (K083784)Vascular Solutions, Inc.2009-03-30
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 (K082382)Possis Medical, Inc.2008-12-12
MODIFICATION TO FETCH ASPIRATION CATHETER (K081989)Possis Medical, Inc.2008-09-26
ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608 (K080806)Possis Medical, Inc.2008-04-04
QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 (K073519)Kensey Nash Corp.2008-03-28
FLEXOR EVAC ASPIRATION CATHETER (K073627)Cook, Inc.2008-03-04
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 (K073441)Possis Medical, Inc.2008-01-24
PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010 (K072810)Vascular Solutions, Inc.2007-12-19
ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS (K072769)Possis Medical, Inc.2007-11-14
THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 (K071826)Fox Hollow Technologies2007-11-09
QXT EXTRACTION CATHETER (K071727)Vascular Solutions, Inc.2007-09-28
ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552 (K072269)Possis Medical, Inc.2007-09-08
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 (K071336)Possis Medical, Inc.2007-08-24
XTRACT CATHETER SYSTEM (K071529)Lumen Biomedical, Inc.2007-08-10
ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039 (K071342)Possis Medical, Inc.2007-07-31
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 (K071514)Possis Medical, Inc.2007-07-31
PRONTO .035 EXTRACTION CATHETER (K070403)Vascular Solutions, Inc.2007-06-13
FETCH ASPIRATION CATHETER (K070363)Possis Medical, Inc.2007-05-11
PRONTO V3 EXTRACTION CATHETER, MODEL 5003 (K063371)Vascular Solutions, Inc.2006-12-14
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120 (K061951)Possis Medical, Inc.2006-11-22
RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135 (K062275)Kerberos Proximal Solutions, Inc.2006-09-20
FETCH ASPIRATION CATHETER (K062172)Possis Medical, Inc.2006-09-20
MEDTRONIC EXPORT XT CATHETER (K061958)Medtronic Vascular2006-09-05
LBI CATHETER SYSTEM (K053372)Lumen Biomedical, Inc.2006-06-30
QUICKCAT EXTRACTION CATHETER (K060092)Kensey Nash Corp.2006-03-09
RIO ASPIRATION CATHETER (K051880)Boston Scientific Corp2006-01-04
ANGIOJET XPEEDIOR 120 CATHETER (K052256)Possis Medical, Inc.2005-11-10
VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER (K052232)Vascular Solutions, Inc.2005-09-28
VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER (K051193)Vascular Solutions, Inc.2005-08-08
DIVER C.E. CATHETER (K051917)Invatec Innovative Technologies, S.R.L.2005-08-08
KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM (K050130)Kerberos Proximal Solutions, Inc.2005-05-13
ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER (K050794)Possis Medical, Inc.2005-04-28
MODIFICATION TO: EXPORT CATHETER (K050139)Medtronic Vascular2005-03-22
DIVER C.E. CATHETER (K050276)Invatec Innovative Technologies, S.R.L.2005-03-07
MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER (K042937)Vascular Solutions, Inc.2005-01-31
ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX) (K042874)Possis Medical, Inc.2004-11-05
EXPORT CATHETER (K040869)Medtronic Vascular2004-06-01
ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT (K040013)Possis Medical, Inc.2004-05-18
VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER (K032763)Vascular Solutions, Inc.2003-12-19
POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C (K972610)Possis Medical, Inc.2000-04-11
6F HYDROLYSER THROMBECTOMY CATHETER (K990771)Cordis Corp.1999-06-25
MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER (K990805)Cordis Corp.1999-03-15
7F HYDROLYSER THROMBECTOMY CATHETER (K983534)Cordis Corp.1999-02-26

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Every clearance here is in the API, with alerts when new ones post.