Product Code: QEY FDA class 2 21 CFR 870.5150

Mechanical Thrombolysis Catheter

Cardiovascular

The Mechanical Thrombolysis Catheter is a catheter device used to mechanically disrupt thrombus and/or debris in the peripheral vasculature, restoring blood flow without the use of aspiration as the primary removal mechanism. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 870.5150 in the Cardiovascular specialty. The product code is QEY. 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: QEY
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 in the peripheral vasculature.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 71 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260149	Versus Catheter (VS110-9NB)	Feb 17, 2026	Substantially Equivalent	Liquet Medical, Inc.
K251318	VariFuse Adjustable Infusion Catheter	Jan 20, 2026	Substantially Equivalent	Argon Medical Devices, Inc.
K241851	Versus Catheter (VS110-8B)	Nov 25, 2024	Substantially Equivalent	Liquet Medical, Inc.
K231653	BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter	Jul 03, 2023	Substantially Equivalent	Thrombolex, Inc.
K222095	BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101	Apr 20, 2023	Substantially Equivalent	Thrombolex, Inc.
K220866	EKOS+ Endovascular Device	Apr 20, 2022	Substantially Equivalent	Boston Scientific
K213422	EkoSonic Endovascular Device, EKOS+ Endovascular Device	Dec 14, 2021	Substantially Equivalent	Boston Scientific Corporation
K211080	EkoSonic Endovascular Device	Nov 19, 2021	Substantially Equivalent	Boston Scientific
K211061	BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240)	Jun 10, 2021	Substantially Equivalent	Thrombolex, Inc.
K202347	UNIFUSE Infusion System with Cooper Wire	Sep 15, 2020	Substantially Equivalent	AngioDynamics, Inc.
K200648	EKOS PE Endovascular Device with Control System 4.0 (CS4.0)	Aug 17, 2020	Substantially Equivalent	Ekos Corporation
K192864	UNI*FUSE Infusion System with Cooper Wire	Jun 01, 2020	Substantially Equivalent	AngioDynamics, Inc.
K193071	Bashir Plus Endovascular Catheter	Dec 17, 2019	Substantially Equivalent	Thrombolex, Inc.
K192598	Bashir S-B Endovascular Catheter, Ref. No. 7101	Oct 18, 2019	Substantially Equivalent	Thrombolex, Inc.
K191119	EkoSonic Endovascular Device	Aug 23, 2019	Substantially Equivalent	Btg International, Inc.
K183361	EkoSonic Endovascular Device with Control Unit 4.0	Apr 05, 2019	Substantially Equivalent	Btg International, Inc.
K183290	Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200	Feb 25, 2019	Substantially Equivalent	Thrombolex, Inc.
K182324	EkoSonic Endovascular System	Nov 26, 2018	Substantially Equivalent	Btg International, Inc.
K163356	Pulse* Spray Infusion System, Uni*Fuse Infusion System	May 30, 2017	Substantially Equivalent	AngioDynamics, Inc.
K162771	EkoSonic Endovascular System with Control Unit 4.0	Feb 24, 2017	Substantially Equivalent	Btg International, Inc.
K170258	SpeedLyser Infusion Catheter Kit	Feb 21, 2017	Substantially Equivalent	AngioDynamics, Inc.
K162777	Squirt Fluid Delivery System	Oct 31, 2016	Substantially Equivalent	Merit Medical Systems, Inc.
K153488	Occlusion Perfusion Catheter	Feb 25, 2016	Substantially Equivalent	Advanced Catheter Therapies, Inc.
K151554	Occlusion Perfusion Catheter	Sep 15, 2015	Substantially Equivalent	Advanced Catheter Therapies, Inc.
K140151	EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT	May 21, 2014	Substantially Equivalent	Btg International, Inc.
K130904	TRELLIS-8 PERIPHERAL INFUSION SYSTEM	Oct 25, 2013	Substantially Equivalent	Covidien
K111705	EKOSONIC ENDOVASCULAR SYSTEM	Aug 03, 2011	Substantially Equivalent	Ekos Corporation
K083335	MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM	Dec 15, 2008	Substantially Equivalent	Omnisonics Medical Technologies
K082199	SPIRALFUSE PERIPHERAL INFUSION SYSTEM	Oct 17, 2008	Substantially Equivalent	Bacchus Vascular, Inc.
K081467	EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION	Jun 26, 2008	Substantially Equivalent	Ekos Corp.
K080392	EndoWave Infusion System	Apr 30, 2008	Substantially Equivalent	Ekos Corp.
K072507	ENDOWAVE INFUSION SYSTEM	Oct 04, 2007	Substantially Equivalent	Ekos Corp.
K071762	OMNIWAVE ENDOVASCULAR SYSTEM	Sep 27, 2007	Substantially Equivalent	Omnisonics Medical Technologies
K071933	ENDOWAVE INFUSION SYSTEM	Aug 10, 2007	Substantially Equivalent	Ekos Corp.
K063620	EKOS MICRO-INFUSION SYSTEM	Aug 06, 2007	Unknown	Ekos Corp.
K071664	TRELLIS-6 PERIPHERAL INFUSION SYSTEM	Jul 13, 2007	Substantially Equivalent	Bacchus Vascular, Inc.
K062507	MICRO-INFUSION SYSTEM	Nov 22, 2006	Substantially Equivalent	Ekos Corp.
K060422	LYSUS INFUSION SYSTEM	Mar 09, 2006	Substantially Equivalent	Ekos Corp.
K060084	LYSUS INFUSION SYSTEM	Feb 07, 2006	Substantially Equivalent	Ekos Corp.
K053432	EKOS MICRO-INFUSION SYSTEM	Dec 30, 2005	Substantially Equivalent	Ekos Corp.
K052428	RESOLUTION ENDOVASCULAR SYSTEM	Dec 08, 2005	Substantially Equivalent	Omnisonics Medical Technologies
K052071	LYSUS INFUSION SYSTEM	Aug 16, 2005	Substantially Equivalent	Ekos Corp.
K051319	LYSUS INFUSION SYSTEM	Jun 15, 2005	Substantially Equivalent	Ekos Corp.
K050563	EKOS PERIPHERAL INFUSION SYSTEM	Mar 29, 2005	Substantially Equivalent	Ekos Corp.
K050147	TRELLIS-8 PERIPHERAL INFUSION SYSTEM	Feb 03, 2005	Substantially Equivalent	Bacchus Vascular, Inc.
K043269	Lysus Infusion System	Dec 22, 2004	Substantially Equivalent	Ekos Corp.
K042456	Lysus Infusion System	Sep 23, 2004	Substantially Equivalent	Ekos Corp.
K041705	RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2	Sep 01, 2004	Substantially Equivalent	Omnisonics Medical Technologies
K041629	LYSUS INFUSION SYSTEM	Aug 06, 2004	Substantially Equivalent	Ekos Corp.
K041517	INFUSIONCATH	Aug 05, 2004	Substantially Equivalent	Id, LLC
K033443	SPEEDLYSER INFUSION CATHETER KIT	Nov 19, 2003	Unknown	AngioDynamics, Inc.
K033214	EKOS PERIPHERAL INFUSION SYSTEM	Oct 14, 2003	Substantially Equivalent	Ekos Corp.
K032261	Trellis Reserve Infusion System	Aug 22, 2003	Substantially Equivalent	Bacchus Vascular, Inc.
K030637	EKOS PERIPHERAL INFUSION SYSTEM	Jul 22, 2003	Substantially Equivalent	Ekos Corp.
K023514	TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH)	Dec 02, 2002	Substantially Equivalent	Bacchus Vascular, Inc.
K021958	TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM (100CM CATHETER LENGTH 10CM INFUSION H	Jul 03, 2002	Substantially Equivalent	Bacchus Vascular, Inc.
K013635	TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH)	Feb 11, 2002	Substantially Equivalent	Bacchus Vascular, Inc.
K992231	FOUNTAIN Infusion Catheter and Occluding Guide Wire	Jul 23, 1999	Substantially Equivalent	Merit Medical Systems, Inc.
K991619	FOUNTAIN Infusion Catheter and Occluding Guide Wire	Jun 09, 1999	Substantially Equivalent	Merit Medical Systems, Inc.
K981417	Squirt Fluid Delivery System	Jul 17, 1998	Substantially Equivalent	Merit Medical Systems, Inc.
K980957	KAPLAN-SIMPSON INFUSASLEEVE II	Jun 10, 1998	Substantially Equivalent	Localmed, Inc.
K974067	FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE	Feb 27, 1998	Substantially Equivalent	Merit Medical Systems, Inc.
K972175	INFUSASLEEVE IIA (IS-2A)	Aug 28, 1997	Substantially Equivalent	Localmed, Inc.
K972110	Cordis Endeavor Infusion Catheter	Aug 14, 1997	Substantially Equivalent	Cordis Corp.
K970842	Cordis Endeavor Infusion Catheter	May 28, 1997	Substantially Equivalent	Cordis Corp.
K961763	PULSE*SPRAY INFUSION SYSTEM	Jul 17, 1996	Substantially Equivalent	Angiodynamics, Div. E-Z-Em, Inc.
K953384	Multi Side Hole lnfusion System	Dec 22, 1995	Substantially Equivalent	AngioDynamics, Inc.
K952317	Kaplan-Simpson InfusaSleeve II Catheter	Jun 28, 1995	Substantially Equivalent	Localmed, Inc.
K951509	PULSE*SPRAY INFUSION SYSTEM	Jun 16, 1995	Substantially Equivalent	Angiodynamics, Div. E-Z-Em, Inc.
K950907	PULSE*SPRAY INFUSION SYSTEM	May 17, 1995	Substantially Equivalent	Angiodynamics, Div. E-Z-Em, Inc.
K950615	KAPLAN-SIMPSON INFUSASLEEVE CATHETER	Apr 19, 1995	Substantially Equivalent	Localmed, Inc.