ClearanceBrief
Panels › Cardiovascular › Product code QEY · Class 2

Mechanical Thrombolysis Catheter

Regulation 870.5150

2510(k)s in 12 months (71 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
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Top companies in QEY

Decided510(k)Device and applicantCode
Feb 17, 2026K260149Versus™ Catheter (VS110-9NB)
Liquet Medical, Inc.
QEY
Jan 20, 2026K251318VariFuse Adjustable Infusion Catheter
Argon Medical Devices, Inc.
QEY
Nov 25, 2024K241851Versus™ Catheter (VS110-8B)
Liquet Medical, Inc.
QEY
Jul 3, 2023K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter
Thrombolex, Inc.
QEY
Apr 20, 2023K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101
Thrombolex, Inc.
QEY
Apr 20, 2022K220866EKOS+ Endovascular Device
Boston Scientific
QEY
Dec 14, 2021K213422EkoSonic Endovascular Device, EKOS+ Endovascular Device
Boston Scientific Corporation
QEY
Nov 19, 2021K211080EkoSonic Endovascular Device
Boston Scientific
QEY
Jun 10, 2021K211061BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular
Thrombolex, Inc.
QEY
Sep 15, 2020K202347UNIFUSE Infusion System with Cooper Wire
AngioDynamics, Inc.
QEY
Aug 17, 2020K200648EKOS PE Endovascular Device with Control System 4.0 (CS4.0)
Ekos Corporation
QEY
Jun 1, 2020K192864UNI*FUSE Infusion System with Cooper Wire
AngioDynamics, Inc.
QEY
Dec 17, 2019K193071Bashir Plus Endovascular Catheter
Thrombolex, Inc.
QEY
Oct 18, 2019K192598Bashir S-B Endovascular Catheter, Ref. No. 7101
Thrombolex, Inc.
QEY
Aug 23, 2019K191119EkoSonic Endovascular Device
Btg International, Inc.
QEY
Apr 5, 2019K183361EkoSonic Endovascular Device with Control Unit 4.0
Btg International, Inc.
QEY
Feb 25, 2019K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200
Thrombolex, Inc.
QEY
Nov 26, 2018K182324EkoSonic Endovascular System
Btg International, Inc.
QEY
May 30, 2017K163356Pulse* Spray Infusion System, Uni*Fuse Infusion System
AngioDynamics, Inc.
QEY
Feb 24, 2017K162771EkoSonic Endovascular System with Control Unit 4.0
Btg International, Inc.
QEY
Feb 21, 2017K170258SpeedLyser Infusion Catheter Kit
AngioDynamics, Inc.
QEY
Oct 31, 2016K162777Squirt Fluid Delivery System
Merit Medical Systems, Inc.
QEY
Feb 25, 2016K153488Occlusion Perfusion Catheter
Advanced Catheter Therapies, Inc.
QEY
Sep 15, 2015K151554Occlusion Perfusion Catheter
Advanced Catheter Therapies, Inc.
QEY
May 21, 2014K140151EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
Btg International, Inc.
QEY
Oct 25, 2013K130904TRELLIS-8 PERIPHERAL INFUSION SYSTEM
Covidien
QEY
Aug 3, 2011K111705EKOSONIC ENDOVASCULAR SYSTEM
Ekos Corporation
QEY
Dec 15, 2008K083335MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM
Omnisonics Medical Technologies
QEY
Oct 17, 2008K082199SPIRALFUSE PERIPHERAL INFUSION SYSTEM
Bacchus Vascular, Inc.
QEY
Jun 26, 2008K081467EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
Ekos Corp.
QEY
Apr 30, 2008K080392EndoWave Infusion System
Ekos Corp.
QEY
Oct 4, 2007K072507ENDOWAVE INFUSION SYSTEM
Ekos Corp.
QEY
Sep 27, 2007K071762OMNIWAVE ENDOVASCULAR SYSTEM
Omnisonics Medical Technologies
QEY
Aug 10, 2007K071933ENDOWAVE INFUSION SYSTEM
Ekos Corp.
QEY
Aug 6, 2007K063620EKOS MICRO-INFUSION SYSTEM
Ekos Corp.
QEY
Jul 13, 2007K071664TRELLIS-6 PERIPHERAL INFUSION SYSTEM
Bacchus Vascular, Inc.
QEY
Nov 22, 2006K062507MICRO-INFUSION SYSTEM
Ekos Corp.
QEY
Mar 9, 2006K060422LYSUS INFUSION SYSTEM
Ekos Corp.
QEY
Feb 7, 2006K060084LYSUS INFUSION SYSTEM
Ekos Corp.
QEY
Dec 30, 2005K053432EKOS MICRO-INFUSION SYSTEM
Ekos Corp.
QEY
Dec 8, 2005K052428RESOLUTION ENDOVASCULAR SYSTEM
Omnisonics Medical Technologies
QEY
Aug 16, 2005K052071LYSUS INFUSION SYSTEM
Ekos Corp.
QEY
Jun 15, 2005K051319LYSUS INFUSION SYSTEM
Ekos Corp.
QEY
Mar 29, 2005K050563EKOS PERIPHERAL INFUSION SYSTEM
Ekos Corp.
QEY
Feb 3, 2005K050147TRELLIS-8 PERIPHERAL INFUSION SYSTEM
Bacchus Vascular, Inc.
QEY
Dec 22, 2004K043269Lysus Infusion System
Ekos Corp.
QEY
Sep 23, 2004K042456Lysus Infusion System
Ekos Corp.
QEY
Sep 1, 2004K041705RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2
Omnisonics Medical Technologies
QEY
Aug 6, 2004K041629LYSUS INFUSION SYSTEM
Ekos Corp.
QEY
Aug 5, 2004K041517INFUSIONCATH
Id, LLC
QEY

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