FDA Product Code
FDA Product Code QEY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5150
510(k) Clearances — 71 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260149 | Versus Catheter (VS110-9NB) | Liquet Medical, Inc. | 2026-02-17 | Special | PDF ↗ |
| K251318 | VariFuse Adjustable Infusion Catheter | Argon Medical Devices, Inc. | 2026-01-20 | Traditional | PDF ↗ |
| K241851 | Versus Catheter (VS110-8B) | Liquet Medical, Inc. | 2024-11-25 | Traditional | PDF ↗ |
| K231653 | BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter | Thrombolex, Inc. | 2023-07-03 | Special | PDF ↗ |
| K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 | Thrombolex, Inc. | 2023-04-20 | Traditional | PDF ↗ |
| K220866 | EKOS+ Endovascular Device | Boston Scientific | 2022-04-20 | Special | PDF ↗ |
| K213422 | EkoSonic Endovascular Device, EKOS+ Endovascular Device | Boston Scientific Corporation | 2021-12-14 | Traditional | PDF ↗ |
| K211080 | EkoSonic Endovascular Device | Boston Scientific | 2021-11-19 | Traditional | PDF ↗ |
| 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) | Thrombolex, Inc. | 2021-06-10 | Traditional | PDF ↗ |
| K202347 | UNIFUSE Infusion System with Cooper Wire | AngioDynamics, Inc. | 2020-09-15 | Special | PDF ↗ |
| K200648 | EKOS PE Endovascular Device with Control System 4.0 (CS4.0) | Ekos Corporation | 2020-08-17 | Special | PDF ↗ |
| K192864 | UNI*FUSE Infusion System with Cooper Wire | AngioDynamics, Inc. | 2020-06-01 | Traditional | PDF ↗ |
| K193071 | Bashir Plus Endovascular Catheter | Thrombolex, Inc. | 2019-12-17 | Traditional | PDF ↗ |
| K192598 | Bashir S-B Endovascular Catheter, Ref. No. 7101 | Thrombolex, Inc. | 2019-10-18 | Special | PDF ↗ |
| K191119 | EkoSonic Endovascular Device | Btg International, Inc. | 2019-08-23 | Special | PDF ↗ |
| K183361 | EkoSonic Endovascular Device with Control Unit 4.0 | Btg International, Inc. | 2019-04-05 | Traditional | PDF ↗ |
| K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 | Thrombolex, Inc. | 2019-02-25 | Traditional | PDF ↗ |
| K182324 | EkoSonic Endovascular System | Btg International, Inc. | 2018-11-26 | Special | PDF ↗ |
| K163356 | Pulse* Spray Infusion System, Uni*Fuse Infusion System | AngioDynamics, Inc. | 2017-05-30 | Traditional | PDF ↗ |
| K162771 | EkoSonic Endovascular System with Control Unit 4.0 | Btg International, Inc. | 2017-02-24 | Traditional | PDF ↗ |
| K170258 | SpeedLyser Infusion Catheter Kit | AngioDynamics, Inc. | 2017-02-21 | Special | PDF ↗ |
| K162777 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 2016-10-31 | Special | PDF ↗ |
| K153488 | Occlusion Perfusion Catheter | Advanced Catheter Therapies, Inc. | 2016-02-25 | Traditional | PDF ↗ |
| K151554 | Occlusion Perfusion Catheter | Advanced Catheter Therapies, Inc. | 2015-09-15 | Traditional | PDF ↗ |
| K140151 | EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT | Btg International, Inc. | 2014-05-21 | Traditional | PDF ↗ |
| K130904 | TRELLIS-8 PERIPHERAL INFUSION SYSTEM | Covidien | 2013-10-25 | Traditional | PDF ↗ |
| K111705 | EKOSONIC ENDOVASCULAR SYSTEM | Ekos Corporation | 2011-08-03 | Traditional | PDF ↗ |
| K083335 | MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM | Omnisonics Medical Technologies | 2008-12-15 | Special | PDF ↗ |
| K082199 | SPIRALFUSE PERIPHERAL INFUSION SYSTEM | Bacchus Vascular, Inc. | 2008-10-17 | Traditional | PDF ↗ |
| K081467 | EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION | Ekos Corp. | 2008-06-26 | Special | PDF ↗ |
| K080392 | EndoWave Infusion System | Ekos Corp. | 2008-04-30 | Special | PDF ↗ |
| K072507 | ENDOWAVE INFUSION SYSTEM | Ekos Corp. | 2007-10-04 | Special | PDF ↗ |
| K071762 | OMNIWAVE ENDOVASCULAR SYSTEM | Omnisonics Medical Technologies | 2007-09-27 | Traditional | PDF ↗ |
| K071933 | ENDOWAVE INFUSION SYSTEM | Ekos Corp. | 2007-08-10 | Special | PDF ↗ |
| K063620 | EKOS MICRO-INFUSION SYSTEM | Ekos Corp. | 2007-08-06 | Traditional | PDF ↗ |
| K071664 | TRELLIS-6 PERIPHERAL INFUSION SYSTEM | Bacchus Vascular, Inc. | 2007-07-13 | Special | PDF ↗ |
| K062507 | MICRO-INFUSION SYSTEM | Ekos Corp. | 2006-11-22 | Special | PDF ↗ |
| K060422 | LYSUS INFUSION SYSTEM | Ekos Corp. | 2006-03-09 | Special | PDF ↗ |
| K060084 | LYSUS INFUSION SYSTEM | Ekos Corp. | 2006-02-07 | Special | PDF ↗ |
| K053432 | EKOS MICRO-INFUSION SYSTEM | Ekos Corp. | 2005-12-30 | Special | PDF ↗ |
| K052428 | RESOLUTION ENDOVASCULAR SYSTEM | Omnisonics Medical Technologies | 2005-12-08 | Traditional | PDF ↗ |
| K052071 | LYSUS INFUSION SYSTEM | Ekos Corp. | 2005-08-16 | Special | PDF ↗ |
| K051319 | LYSUS INFUSION SYSTEM | Ekos Corp. | 2005-06-15 | Special | PDF ↗ |
| K050563 | EKOS PERIPHERAL INFUSION SYSTEM | Ekos Corp. | 2005-03-29 | Special | PDF ↗ |
| K050147 | TRELLIS-8 PERIPHERAL INFUSION SYSTEM | Bacchus Vascular, Inc. | 2005-02-03 | Special | PDF ↗ |
| K043269 | Lysus Infusion System | Ekos Corp. | 2004-12-22 | Special | PDF ↗ |
| K042456 | Lysus Infusion System | Ekos Corp. | 2004-09-23 | Special | PDF ↗ |
| K041705 | RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 | Omnisonics Medical Technologies | 2004-09-01 | Traditional | PDF ↗ |
| K041629 | LYSUS INFUSION SYSTEM | Ekos Corp. | 2004-08-06 | Traditional | PDF ↗ |
| K041517 | INFUSIONCATH | Id, LLC | 2004-08-05 | Traditional | PDF ↗ |
| K033443 | SPEEDLYSER INFUSION CATHETER KIT | AngioDynamics, Inc. | 2003-11-19 | Special | PDF ↗ |
| K033214 | EKOS PERIPHERAL INFUSION SYSTEM | Ekos Corp. | 2003-10-14 | Special | PDF ↗ |
| K032261 | Trellis Reserve Infusion System | Bacchus Vascular, Inc. | 2003-08-22 | Special | PDF ↗ |
| K030637 | EKOS PERIPHERAL INFUSION SYSTEM | Ekos Corp. | 2003-07-22 | Traditional | PDF ↗ |
| K023514 | TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH) | Bacchus Vascular, Inc. | 2002-12-02 | Traditional | PDF ↗ |
| K021958 | TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM (100CM CATHETER LENGTH 10CM INFUSION H | Bacchus Vascular, Inc. | 2002-07-03 | Special | PDF ↗ |
| K013635 | TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH) | Bacchus Vascular, Inc. | 2002-02-11 | Traditional | PDF ↗ |
| K992231 | FOUNTAIN Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1999-07-23 | Special | PDF ↗ |
| K991619 | FOUNTAIN Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1999-06-09 | Special | PDF ↗ |
| K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998-07-17 | Traditional | PDF ↗ |
| K980957 | KAPLAN-SIMPSON INFUSASLEEVE II | Localmed, Inc. | 1998-06-10 | Traditional | PDF ↗ |
| K974067 | FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE | Merit Medical Systems, Inc. | 1998-02-27 | Traditional | PDF ↗ |
| K972175 | INFUSASLEEVE IIA (IS-2A) | Localmed, Inc. | 1997-08-28 | Traditional | PDF ↗ |
| K972110 | Cordis Endeavor Infusion Catheter | Cordis Corp. | 1997-08-14 | Traditional | PDF ↗ |
| K970842 | Cordis Endeavor Infusion Catheter | Cordis Corp. | 1997-05-28 | Traditional | PDF ↗ |
| K961763 | PULSE*SPRAY INFUSION SYSTEM | Angiodynamics, Div. E-Z-Em, Inc. | 1996-07-17 | Traditional | PDF ↗ |
| K953384 | Multi Side Hole lnfusion System | AngioDynamics, Inc. | 1995-12-22 | Traditional | PDF ↗ |
| K952317 | Kaplan-Simpson InfusaSleeve II Catheter | Localmed, Inc. | 1995-06-28 | Traditional | PDF ↗ |
| K951509 | PULSE*SPRAY INFUSION SYSTEM | Angiodynamics, Div. E-Z-Em, Inc. | 1995-06-16 | Traditional | PDF ↗ |
| K950907 | PULSE*SPRAY INFUSION SYSTEM | Angiodynamics, Div. E-Z-Em, Inc. | 1995-05-17 | Traditional | PDF ↗ |
| K950615 | KAPLAN-SIMPSON INFUSASLEEVE CATHETER | Localmed, Inc. | 1995-04-19 | Traditional | PDF ↗ |
Product code QEY · Class II · Cardiovascular. Data: openFDA.