Mechanical Thrombolysis Catheter
FDA product code QEY · 69 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.5150
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1995-04-19 – 2026-02-17
To mechanically disrupt thrombus and/or debris in the peripheral vasculature.
QEY
2026-02-17
QEY
2026-01-20
VariFuse Adjustable Infusion Catheter
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QEY
2024-11-25
Versus™ Catheter (VS110-8B)
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QEY
2023-07-03
BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter
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QEY
2023-04-20
BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101
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QEY
2022-04-20
EKOS+ Endovascular Device
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QEY
2021-12-14
EkoSonic Endovascular Device, EKOS+ Endovascular Device
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QEY
2021-11-19
EkoSonic Endovascular Device
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QEY
2021-06-10
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)
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QEY
2020-09-15
UNIFUSE Infusion System with Cooper Wire
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QEY
2020-08-17
EKOS PE Endovascular Device with Control System 4.0 (CS4.0)
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QEY
2020-06-01
UNI*FUSE Infusion System with Cooper Wire
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QEY
2019-12-17
Bashir Plus Endovascular Catheter
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QEY
2019-10-18
Bashir S-B Endovascular Catheter, Ref. No. 7101
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QEY
2019-08-23
EkoSonic Endovascular Device
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QEY
2019-04-05
EkoSonic Endovascular Device with Control Unit 4.0
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QEY
2019-02-25
Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200
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QEY
2018-11-26
EkoSonic Endovascular System
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QEY
2017-05-30
Pulse* Spray Infusion System, Uni*Fuse Infusion System
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QEY
2017-02-24
EkoSonic Endovascular System with Control Unit 4.0
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QEY
2017-02-21
SpeedLyser Infusion Catheter Kit
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QEY
2016-10-31
Squirt Fluid Delivery System
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QEY
2016-02-25
Occlusion Perfusion Catheter
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QEY
2013-10-25
TRELLIS-8 PERIPHERAL INFUSION SYSTEM
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QEY
2011-08-03
EKOSONIC ENDOVASCULAR SYSTEM
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QEY
2008-12-15
MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM
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QEY
2008-10-17
SPIRALFUSE PERIPHERAL INFUSION SYSTEM
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QEY
2008-06-26
EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
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QEY
2008-04-30
EndoWave Infusion System
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QEY
2007-10-04
ENDOWAVE INFUSION SYSTEM
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QEY
2007-09-27
OMNIWAVE ENDOVASCULAR SYSTEM
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QEY
2007-08-10
ENDOWAVE INFUSION SYSTEM
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QEY
2007-08-06
EKOS MICRO-INFUSION SYSTEM
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QEY
2007-07-13
TRELLIS-6 PERIPHERAL INFUSION SYSTEM
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QEY
2006-11-22
MICRO-INFUSION SYSTEM
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QEY
2006-03-09
LYSUS INFUSION SYSTEM
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QEY
2006-02-07
LYSUS INFUSION SYSTEM
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QEY
2005-12-30
EKOS MICRO-INFUSION SYSTEM
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QEY
2005-12-08
RESOLUTION ENDOVASCULAR SYSTEM
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QEY
2005-08-16
LYSUS INFUSION SYSTEM
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QEY
2005-06-15
LYSUS INFUSION SYSTEM
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QEY
2005-03-29
EKOS PERIPHERAL INFUSION SYSTEM
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QEY
2005-02-03
TRELLIS-8 PERIPHERAL INFUSION SYSTEM
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QEY
2004-12-22
Lysus Infusion System
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QEY
2004-09-23
Lysus Infusion System
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QEY
2004-09-01
RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2
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QEY
2004-08-06
LYSUS INFUSION SYSTEM
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QEY
2004-08-05
INFUSIONCATH
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QEY
2003-11-19
SPEEDLYSER INFUSION CATHETER KIT
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QEY
2003-10-14
EKOS PERIPHERAL INFUSION SYSTEM
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QEY
2003-08-22
Trellis Reserve Infusion System
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QEY
2003-07-22
EKOS PERIPHERAL INFUSION SYSTEM
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QEY
2002-12-02
TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH)
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QEY
2002-07-03
TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM (100CM CATHETER LENGTH 10CM INFUSION H
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QEY
2002-02-11
TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH)
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QEY
1999-07-23
FOUNTAIN Infusion Catheter and Occluding Guide Wire
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QEY
1999-06-09
FOUNTAIN Infusion Catheter and Occluding Guide Wire
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QEY
1998-07-17
Squirt Fluid Delivery System
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QEY
1998-06-10
KAPLAN-SIMPSON INFUSASLEEVE II
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QEY
1998-02-27
FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE
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QEY
1997-08-28
INFUSASLEEVE IIA (IS-2A)
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QEY
1997-08-14
Cordis Endeavor Infusion Catheter
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QEY
1997-05-28
Cordis Endeavor Infusion Catheter
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QEY
1996-07-17
PULSE*SPRAY INFUSION SYSTEM
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QEY
1995-12-22
Multi Side Hole lnfusion System
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QEY
1995-06-28
Kaplan-Simpson InfusaSleeve II Catheter
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QEY
1995-06-16
PULSE*SPRAY INFUSION SYSTEM
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QEY
1995-05-17
PULSE*SPRAY INFUSION SYSTEM
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QEY
1995-04-19
KAPLAN-SIMPSON INFUSASLEEVE CATHETER
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