FDA 510(k) Applications for Medical Device Product Code "QEY"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K153488 | Advanced Catheter Therapies, Inc. | Occlusion Perfusion Catheter | 02/25/2016 |
| K151554 | ADVANCED CATHETER THERAPIES, INC. | Occlusion Perfusion Catheter | 09/15/2015 |
| K961763 | ANGIODYNAMICS, DIV. E-Z-EM, INC. | PULSE*SPRAY INFUSION SYSTEM | 07/17/1996 |
| K163356 | ANGIODYNAMICS, INC. | Pulse* Spray Infusion System, Uni*Fuse Infusion System | 05/30/2017 |
| K033443 | ANGIODYNAMICS, INC. | SPEEDLYSER INFUSION CATHETER KIT | 11/19/2003 |
| K170258 | AngioDynamics, Inc. | SpeedLyser Infusion Catheter Kit | 02/21/2017 |
| K192864 | Angiodynamics, Inc. | UNI*FUSE Infusion System with Cooper Wire | 06/01/2020 |
| K202347 | AngioDynamics, Inc. | UNIFUSE Infusion System with Cooper Wire | 09/15/2020 |
| K082199 | BACCHUS VASCULAR, INC. | SPIRALFUSE PERIPHERAL INFUSION SYSTEM | 10/17/2008 |
| K013635 | BACCHUS VASCULAR, INC. | TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH) | 02/11/2002 |
| K021958 | BACCHUS VASCULAR, INC. | TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM (100CM CATHETER LENGTH 10CM INFUSION H | 07/03/2002 |
| K032261 | BACCHUS VASCULAR, INC. | Trellis Reserve Infusion System | 08/22/2003 |
| K071664 | BACCHUS VASCULAR, INC. | TRELLIS-6 PERIPHERAL INFUSION SYSTEM | 07/13/2007 |
| K023514 | BACCHUS VASCULAR, INC. | TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH) | 12/02/2002 |
| K050147 | BACCHUS VASCULAR, INC. | TRELLIS-8 PERIPHERAL INFUSION SYSTEM | 02/03/2005 |
| K220866 | Boston Scientific | EKOS+ Endovascular Device | 04/20/2022 |
| K211080 | Boston Scientific | EkoSonic Endovascular Device | 11/19/2021 |
| K213422 | Boston Scientific Corporation | EkoSonic Endovascular Device, EKOS+ Endovascular Device | 12/14/2021 |
| K191119 | BTG International, Inc. | EkoSonic Endovascular Device | 08/23/2019 |
| K183361 | BTG International, Inc. | EkoSonic Endovascular Device with Control Unit 4.0 | 04/05/2019 |
| K182324 | BTG International, Inc. | EkoSonic Endovascular System | 11/26/2018 |
| K162771 | BTG International, Inc. | EkoSonic Endovascular System with Control Unit 4.0 | 02/24/2017 |
| K140151 | BTG INTERNATIONAL, INC. | EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT | 05/21/2014 |
| K970842 | CORDIS CORP. | Cordis Endeavor Infusion Catheter | 05/28/1997 |
| K972110 | CORDIS CORP. | Cordis Endeavor Infusion Catheter | 08/14/1997 |
| K130904 | COVIDIEN | TRELLIS-8 PERIPHERAL INFUSION SYSTEM | 10/25/2013 |
| K063620 | EKOS CORP. | EKOS MICRO-INFUSION SYSTEM | 08/06/2007 |
| K053432 | EKOS CORP. | EKOS MICRO-INFUSION SYSTEM | 12/30/2005 |
| K030637 | EKOS CORP. | EKOS PERIPHERAL INFUSION SYSTEM | 07/22/2003 |
| K033214 | EKOS CORP. | EKOS PERIPHERAL INFUSION SYSTEM | 10/14/2003 |
| K050563 | EKOS CORP. | EKOS PERIPHERAL INFUSION SYSTEM | 03/29/2005 |
| K081467 | EKOS CORP. | EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION | 06/26/2008 |
| K071933 | EKOS CORP. | ENDOWAVE INFUSION SYSTEM | 08/10/2007 |
| K072507 | EKOS CORP. | ENDOWAVE INFUSION SYSTEM | 10/04/2007 |
| K080392 | EKOS CORP. | EndoWave Infusion System | 04/30/2008 |
| K041629 | EKOS CORP. | LYSUS INFUSION SYSTEM | 08/06/2004 |
| K042456 | EKOS CORP. | Lysus Infusion System | 09/23/2004 |
| K043269 | EKOS CORP. | Lysus Infusion System | 12/22/2004 |
| K051319 | EKOS CORP. | LYSUS INFUSION SYSTEM | 06/15/2005 |
| K052071 | EKOS CORP. | LYSUS INFUSION SYSTEM | 08/16/2005 |
| K060084 | EKOS CORP. | LYSUS INFUSION SYSTEM | 02/07/2006 |
| K060422 | EKOS CORP. | LYSUS INFUSION SYSTEM | 03/09/2006 |
| K062507 | EKOS CORP. | MICRO-INFUSION SYSTEM | 11/22/2006 |
| K200648 | EKOS Corporation | EKOS PE Endovascular Device with Control System 4.0 (CS4.0) | 08/17/2020 |
| K111705 | EKOS CORPORATION | EKOSONIC ENDOVASCULAR SYSTEM | 08/03/2011 |
| K041517 | ID LLC | INFUSIONCATH | 08/05/2004 |
| K972175 | LOCALMED, INC. | INFUSASLEEVE IIA (IS-2A) | 08/28/1997 |
| K980957 | LOCALMED, INC. | KAPLAN-SIMPSON INFUSASLEEVE II | 06/10/1998 |
| K974067 | MERIT MEDICAL SYSTEMS, INC. | FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE | 02/27/1998 |
| K991619 | MERIT MEDICAL SYSTEMS, INC. | FOUNTAIN Infusion Catheter and Occluding Guide Wire | 06/09/1999 |
| K992231 | MERIT MEDICAL SYSTEMS, INC. | FOUNTAIN Infusion Catheter and Occluding Guide Wire | 07/23/1999 |
| K162777 | Merit Medical Systems, Inc. | Squirt Fluid Delivery System | 10/31/2016 |
| K981417 | MERIT MEDICAL SYSTEMS, INC. | Squirt Fluid Delivery System | 07/17/1998 |
| K083335 | OMNISONICS MEDICAL TECHNOLOGIES | MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM | 12/15/2008 |
| K071762 | OMNISONICS MEDICAL TECHNOLOGIES | OMNIWAVE ENDOVASCULAR SYSTEM | 09/27/2007 |
| K052428 | OMNISONICS MEDICAL TECHNOLOGIES | RESOLUTION ENDOVASCULAR SYSTEM | 12/08/2005 |
| K041705 | OMNISONICS MEDICAL TECHNOLOGIES | RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 | 09/01/2004 |
| K211061 | Thrombolex, Inc. | 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) | 06/10/2021 |
| K183290 | Thrombolex, Inc. | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 | 02/25/2019 |
| K222095 | Thrombolex, Inc. | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 | 04/20/2023 |
| K193071 | Thrombolex, Inc. | Bashir Plus Endovascular Catheter | 12/17/2019 |
| K192598 | Thrombolex, Inc. | Bashir S-B Endovascular Catheter, Ref. No. 7101 | 10/18/2019 |
| K231653 | Thrombolex, Inc. | BASHIRÖ .035 Endovascular Catheter, BASHIRÖ S-B .035 Endovascular Catheter | 07/03/2023 |
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