Product Code: QEW FDA class 2 21 CFR 870.5150

Peripheral Mechanical Thrombectomy With Aspiration

Cardiovascular

The Peripheral Mechanical Thrombectomy With Aspiration device is a cardiovascular device designed to mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration, used in the treatment of peripheral vascular occlusions. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 870.5150 in the Cardiovascular specialty. The product code is QEW. It is not an implant and is not life-sustaining.

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510(k)s

141

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: QEW
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 mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 141 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260599	INDIGO® Aspiration System INDIGO Link	Apr 24, 2026	Substantially Equivalent	Penumbra, Inc.
K260028	CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister	Feb 05, 2026	Substantially Equivalent	Argon Medical Devices, Inc.
K251949	INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK	Feb 05, 2026	Substantially Equivalent	Penumbra, Inc.
K253730	RoVo Mechanical Thrombectomy System	Jan 21, 2026	Substantially Equivalent	Verge Medical, Inc.
K251207	Sangria Thrombectomy System	Jan 07, 2026	Substantially Equivalent	Avantec Vascular Corporation
K252956	Helo Thrombectomy System	Dec 18, 2025	Substantially Equivalent	Endovascular Engineering, Inc.
K251070	Akura Thrombectomy System	Nov 25, 2025	Substantially Equivalent	Akura Medical
K253323	Protrieve Sheath	Oct 29, 2025	Substantially Equivalent	Inari Medical
K251185	Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)	Oct 22, 2025	Substantially Equivalent	Intervene
K252612	INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing	Oct 16, 2025	Substantially Equivalent	Penumbra, Inc.
K252057	Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System	Aug 28, 2025	Substantially Equivalent	Imperative Care, Inc.
K251485	Excipio LV Prime Thrombectomy Device	Jun 13, 2025	Substantially Equivalent	Contego Medical, Inc.
K251189	Aventus Thrombectomy System	Jun 13, 2025	Substantially Equivalent	Inquis Medical
K250787	Liberant Thrombectomy System	Jun 11, 2025	Substantially Equivalent	Medtronic, Ireland
K250775	Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy System	May 14, 2025	Substantially Equivalent	Imperative Care, Inc.
K250421	InThrill Thrombectomy System	May 12, 2025	Substantially Equivalent	Inari Medical, Inc.
K250668	Aventus Thrombectomy System (IM-2100)	Mar 25, 2025	Substantially Equivalent	Inquis Medical
K250088	FlowTriever2 Catheter	Mar 13, 2025	Substantially Equivalent	Inari Medical, Inc.
K250202	Aventus Thrombectomy System	Feb 26, 2025	Substantially Equivalent	Inquis Medical
K241894	Artix MT; Artix Thin-Walled Thrombectomy Sheath	Oct 15, 2024	Substantially Equivalent	Inari Medical, Inc.
K242557	ClotTriever XL Catheter (41-102)	Sep 27, 2024	Substantially Equivalent	Inari Medical, Inc.
K242075	Indigo® Aspiration System Lightning Bolt Aspiration Tubing	Sep 25, 2024	Substantially Equivalent	Penumbra, Inc.
K241362	Pounce XL Thrombectomy System (PTS-1011-7F135)	Sep 11, 2024	Substantially Equivalent	Surmodics,Inc.
K242319	Indigo® Aspiration System Aspiration Catheter 6X	Sep 03, 2024	Substantially Equivalent	Penumbra, Inc.
K233917	ICHOR 7F Embolectomy System (ICH-7F)	Jul 18, 2024	Substantially Equivalent	Ichor
K241399	Indigo® Lightning Flash Aspiration System Select + Catheter	Jun 10, 2024	Substantially Equivalent	Penumbra, Inc.
K241207	SmartClaw Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw Thrombectomy Catheter, 32 mm (FD0660-02)	May 29, 2024	Substantially Equivalent	Devoro Medical, Inc.
K234073	ICE Aspiration System	Apr 19, 2024	Substantially Equivalent	Expanse Medical, Inc.
K233909	Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner Plus 18F Handpiece with Maceration Wire, Cleaner Plus 18F Aspiration Canister	Mar 28, 2024	Substantially Equivalent	Argon Medical Devices, Inc.
K240117	Aventus Thrombectomy System (IM-2001/IM-0002)	Mar 15, 2024	Substantially Equivalent	Inquis Medical
K234034	VenaCore Thrombectomy Catheter (46-101)	Feb 09, 2024	Substantially Equivalent	Inari Medical, Inc.
K240030	Indigo® Aspiration System - Lightning® Flash	Feb 02, 2024	Substantially Equivalent	Penumbra, Inc.
K232679	Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister	Jan 19, 2024	Substantially Equivalent	Argon Medical Devices, Inc.
K233815	ClotTriever Sheath	Dec 18, 2023	Substantially Equivalent	Inari Medical, Inc.
K232730	Aventus Thrombectomy System	Nov 01, 2023	Substantially Equivalent	Inquis Medical
K230743	ICHOR 14F Embolectomy System	Sep 05, 2023	Substantially Equivalent	Ichor
K231848	Triever20 Curve (21-201)	Jul 21, 2023	Substantially Equivalent	Inari Medical, Inc.
K231022	Pounce Thrombectomy System	Jun 12, 2023	Substantially Equivalent	Surmodics,Inc.
K223929	Laguna Clot Retriever System and Malibu Aspiration Catheter System (Laguna Thrombectomy System)	Jun 01, 2023	Substantially Equivalent	Innova Vascular, Inc.
K230030	Excipio SV Aspiration Catheter and Tubing	May 30, 2023	Substantially Equivalent	Contego Medical, Inc.
K230912	Artix BG	May 02, 2023	Substantially Equivalent	Inari Medical
K223210	ClotTriever XL Catheter	Apr 27, 2023	Substantially Equivalent	Inari Medical, Inc.
K230494	ClotTriever BOLD Catheter	Apr 18, 2023	Substantially Equivalent	Inari Medical, Inc.
K230356	Aspirex Thrombectomy System	Mar 31, 2023	Substantially Equivalent	C.R. Bard, Inc.
K220780	ROVO Mechanical Thrombectomy Device	Mar 31, 2023	Substantially Equivalent	2mg, Inc.
K223419	Triever16 Curve	Mar 23, 2023	Substantially Equivalent	Inari Medical
K223613	InThrill Thrombectomy System	Mar 17, 2023	Substantially Equivalent	Inari Medical, Inc.
K223609	RevCore Thrombectomy Catheter.	Mar 14, 2023	Substantially Equivalent	Inari Medical, Inc.
K230331	Protrieve Sheath	Mar 07, 2023	Substantially Equivalent	Inari Medical, Inc.
K223436	Artix AX	Mar 02, 2023	Substantially Equivalent	Inari Medical
K223216	Symphony Thrombectomy System	Feb 23, 2023	Substantially Equivalent	Truvic Medical, Inc.
K223897	Excipio LV Thrombectomy Device	Feb 17, 2023	Substantially Equivalent	Contego Medical, Inc.
K223891	Cobra Catheter System	Feb 15, 2023	Substantially Equivalent	Endovascular Engineering
K223186	Indigo® Aspiration System Lightning Bolt Aspiration Tubing	Feb 13, 2023	Substantially Equivalent	Penumbra, Inc.
K221531	ClotTriever Thrombectomy System	Feb 06, 2023	Substantially Equivalent	Inari Medical, Inc.
K223000	Artix BG	Jan 11, 2023	Substantially Equivalent	Inari Medical
K222358	Indigo Aspiration System - Lightning Flash	Dec 20, 2022	Substantially Equivalent	Penumbra, Inc.
K221391	WOLF Thrombectomy SmartClaw Catheter	Nov 10, 2022	Substantially Equivalent	Devoro Medical, Inc.
K220683	INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)	Oct 04, 2022	Unknown	Penumbra, Inc.
K220887	Mini-ClotTriever Thrombectomy System	Aug 04, 2022	Substantially Equivalent	Inari Medical
K220415	Protrieve Sheath	Jul 12, 2022	Substantially Equivalent	Inari Medical, Inc.
K221204	Excipio SV Thrombectomy Device	Jun 23, 2022	Substantially Equivalent	Contego Medical, Inc.
K220270	Aspirex Thrombectomy System	Jun 21, 2022	Substantially Equivalent	C.R. Bard, Inc.
K213402	Triever24, Triever20	May 23, 2022	Substantially Equivalent	Inari Medical
K214114	Prodigy Thrombectomy System	Apr 06, 2022	Substantially Equivalent	Truvic Medical, Inc.
K220600	Artix Thrombectomy Device	Mar 25, 2022	Substantially Equivalent	Inari Medical
K220501	Pounce Thrombectomy System	Mar 23, 2022	Substantially Equivalent	Surmodics,Inc.
K211798	Cleaner Plus Thrombectomy System	Feb 24, 2022	Substantially Equivalent	Argon Medical Devices, Inc.
K210911	WOLF Thrombectomy System, 14F	Oct 19, 2021	Substantially Equivalent	Devoro Medical, Inc.
K212632	ClotTriever Thrombectomy System	Oct 18, 2021	Substantially Equivalent	Inari Medical, Inc.
K210530	WOLF Thrombectomy System, 6F	Aug 27, 2021	Substantially Equivalent	Devoro Medical, Inc.
K211492	Pounce Thrombectomy System	Jul 30, 2021	Substantially Equivalent	Surmodics,Inc.
K210689	ClotTriever Thrombectomy System	May 12, 2021	Substantially Equivalent	Inari Medical, Inc.
K211013	FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24	Apr 30, 2021	Substantially Equivalent	Inari Medical, Inc.
K210323	Indigo Aspiration System - Lightning Aspiration Tubing	Feb 26, 2021	Substantially Equivalent	Penumbra, Inc.
K210195	Triever Catheters	Feb 24, 2021	Substantially Equivalent	Inari Medical
K210190	ClotTriever Thrombectomy System	Feb 23, 2021	Substantially Equivalent	Irani Medical, Inc.
K210083	Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7	Feb 09, 2021	Substantially Equivalent	Penumbra, Inc.
K201085	NeVa PV Thrombectomy Device	Jan 15, 2021	Substantially Equivalent	Vesalio
K203476	CAPERE Thrombectomy System	Dec 22, 2020	Substantially Equivalent	Vascular Medcure, Inc.
K201705	ReVene Thrombectomy Catheter	Dec 22, 2020	Substantially Equivalent	Vetex Medical, Ltd.
K202345	FlowTriever Retrieval/Aspiration System	Dec 18, 2020	Substantially Equivalent	Inari Medical
K203333	Triever20 Curve Catheter	Dec 10, 2020	Substantially Equivalent	Inari Medical, Inc.
K201541	FlowTriever Retrieval/Aspiration System	Dec 04, 2020	Substantially Equivalent	Inari Medical
K202821	Indigo Aspiration System - Aspiration Catheter 12 and Separator 12	Nov 18, 2020	Substantially Equivalent	Penumbra, Inc.
K202218	ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device	Oct 02, 2020	Substantially Equivalent	Boston Scientific Corporation
K192814	Pounce Thrombus Retrieval System	Sep 21, 2020	Substantially Equivalent	Surmodics,Inc.
K193462	ClotTriever Thrombectomy System	Sep 09, 2020	Substantially Equivalent	Inari Medical
K193595	Indigo Aspiration System - Aspiration Catheter 7 and Separator 7	Aug 19, 2020	Substantially Equivalent	Penumbra, Inc.
K201216	CAPERE Thrombectomy System	Jul 08, 2020	Substantially Equivalent	Vascular Medcure, Inc.
K192981	Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12	May 28, 2020	Substantially Equivalent	Penumbra, Inc.
K200101	WOLF Thrombectomy V System	Apr 27, 2020	Substantially Equivalent	Devoro Medical, Inc.
K200771	Indigo Aspiration System Lightning Aspiration Tubing	Apr 22, 2020	Substantially Equivalent	Penumbra, Inc.
K193244	Indigo Aspiration System Lightning Aspiration Tubing	Mar 13, 2020	Substantially Equivalent	Penumbra, Inc.
K200314	Capere Thrombectomy System	Mar 04, 2020	Substantially Equivalent	Vascular Medcure, Inc.
K192833	Indigo Aspiration System	Dec 20, 2019	Substantially Equivalent	Penumbra, Inc.
K192935	CAPERE Thrombectomy System	Nov 15, 2019	Substantially Equivalent	Vascular Medcure, Inc.
K192332	ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath	Sep 20, 2019	Substantially Equivalent	Inari Medical
K191710	FlowTriever Retrieval/Aspiration System	Sep 05, 2019	Substantially Equivalent	Inari Medical
K192036	ClotTriever Thrombectomy System	Aug 29, 2019	Substantially Equivalent	Inari Medical
K191368	FlowTriever Retrieval/Aspiration System	Jun 17, 2019	Substantially Equivalent	Inari Medical
K182835	WOLF Thrombectomy Device	Mar 27, 2019	Substantially Equivalent	880 Medical, LLC
K183179	CAPERE Thrombectomy System	Feb 25, 2019	Substantially Equivalent	Vascular Medcure, Inc.
K182167	The ICHOR Panacea Vascular Embolectomy Catheter System	Dec 21, 2018	Substantially Equivalent	Ichor Vascular, Inc.
K183198	FlowTriever Retrieval/Aspiration System	Dec 17, 2018	Substantially Equivalent	Inari Medical
K182233	FlowTriever Retrieval/Aspiration System	Oct 15, 2018	Substantially Equivalent	Inari Medical
K182531	ClotTriever Thrombectomy System	Oct 10, 2018	Substantially Equivalent	Inari Medical
K181694	FlowTriever Retrieval/Aspiration System	Jul 27, 2018	Substantially Equivalent	Inari Medical
K181325	FlowTriever Retrieval/Aspiration System	Jun 17, 2018	Substantially Equivalent	Inari Medical, Inc.
K180722	CAPERE Thrombectomy System	Jun 11, 2018	Substantially Equivalent	Kp Medcure, Inc.
K180466	FlowTriever Retrieval/Aspiration System	May 17, 2018	Substantially Equivalent	Inari Medical, Inc.
K180412	Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister	May 15, 2018	Substantially Equivalent	Penumbra, Inc.
K180939	Indigo Aspiration System - Modified 110 Aspiration Tubing	May 03, 2018	Substantially Equivalent	Penumbra, Inc.
K180329	ClotTriever Thrombectomy System	Apr 09, 2018	Substantially Equivalent	Inari Medical, Inc.
K180105	Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister	Mar 08, 2018	Substantially Equivalent	Penumbra, Inc.
K173672	FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter	Feb 05, 2018	Substantially Equivalent	Inari Medical
K172716	V2K Rinspiration System	Jan 26, 2018	Substantially Equivalent	V2k Medical, Inc.
K173470	ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath	Dec 04, 2017	Substantially Equivalent	Inari Medical
K163549	ClotTriever Thrombectomy System	Feb 16, 2017	Substantially Equivalent	Inari Medical, Inc.
K162970	FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator	Nov 22, 2016	Substantially Equivalent	Inari Medical
K161506	Penumbra Aspiration System	Sep 26, 2016	Substantially Equivalent	Penumbra, Inc.
K161523	INDIGO Aspiration System	Jul 01, 2016	Substantially Equivalent	Penumbra, Inc.
K160533	Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)	May 24, 2016	Substantially Equivalent	Penumbra, Inc.
K151313	ZelanteDVT Thrombectomy Set	Sep 21, 2015	Substantially Equivalent	Boston Scientific Corporation
K152097	Retraction Aspirator	Aug 25, 2015	Substantially Equivalent	Inari Medical
K142870	Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]	May 26, 2015	Substantially Equivalent	Penumbra, Inc.
K143563	Infusion Aspiration Catheter System	Feb 03, 2015	Substantially Equivalent	Inari Medical, Inc.
K141617	CLEANER ROTATIONAL THROMBECTOMY SYSTEM	Nov 14, 2014	Substantially Equivalent	Rex Medical, L.P.
K133629	ANGIOJET ULTRA AVX THROMBECTOMY SET	Feb 14, 2014	Substantially Equivalent	Possis Medical, Inc.
K132281	ReVive PV (Peripheral Vasculature) Thrombectomy Device	Aug 30, 2013	Substantially Equivalent	Codman & Shurtleff, Inc.
K130381	ANGIOJET ULTRA POWER PULSE KIT	Jul 29, 2013	Substantially Equivalent	Medrad, Inc.
K121917	PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM	Sep 19, 2012	Substantially Equivalent	Penumbra, Inc.
K092623	F.A.S.T. SYSTEM SED AND CXD	Oct 30, 2009	Substantially Equivalent	Genesis Medical Interventional, Inc.
K090932	NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000	Sep 24, 2009	Substantially Equivalent	Nexgen Medical Systems, Inc.
K083370	D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006	Dec 12, 2008	Substantially Equivalent	Artegraft, Inc.
K080901	LBI EMBOLECTOMY SYSTEM	Oct 02, 2008	Unknown	Lumen Biomedical, Inc.
K041374	AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060	Mar 02, 2005	Substantially Equivalent	Idev Technologies, Inc.
K040010	GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS	Jul 19, 2004	Substantially Equivalent	Genesis Medical Interventional, Inc.
K021641	XTD THROMBECTOMY CATHETER, XX CM	Jul 26, 2002	Substantially Equivalent	Xtrak Medical, Inc.
K011056	ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD	Oct 24, 2001	Substantially Equivalent	Arrow Intl., Inc.
K991093	MSD EMBOLECTOMY BASKET	Dec 21, 2000	Substantially Equivalent	Metamorphic Surgical Devices, LLC