Product code QEY
- Device name
- Mechanical Thrombolysis Catheter
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.5150
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To mechanically disrupt thrombus and/or debris in the peripheral vasculature.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260149 | Versus™ Catheter (VS110-9NB) | Liquet Medical, Inc. | 2026-02-17 |
| K251318 | VariFuse Adjustable Infusion Catheter | Argon Medical Devices, Inc. | 2026-01-20 |
| K241851 | Versus™ Catheter (VS110-8B) | Liquet Medical, Inc. | 2024-11-25 |
| K231653 | BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter | Thrombolex, Inc. | 2023-07-03 |
| K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 | Thrombolex, Inc. | 2023-04-20 |
| K220866 | EKOS+ Endovascular Device | Boston Scientific | 2022-04-20 |
| K213422 | EkoSonic Endovascular Device, EKOS+ Endovascular Device | Boston Scientific Corporation | 2021-12-14 |
| K211080 | EkoSonic Endovascular Device | Boston Scientific | 2021-11-19 |
| 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 |
| K202347 | UNIFUSE Infusion System with Cooper Wire | AngioDynamics, Inc. | 2020-09-15 |
| K200648 | EKOS PE Endovascular Device with Control System 4.0 (CS4.0) | Ekos Corporation | 2020-08-17 |
| K192864 | UNI*FUSE Infusion System with Cooper Wire | AngioDynamics, Inc. | 2020-06-01 |
| K193071 | Bashir Plus Endovascular Catheter | Thrombolex, Inc. | 2019-12-17 |
| K192598 | Bashir S-B Endovascular Catheter, Ref. No. 7101 | Thrombolex, Inc. | 2019-10-18 |
| K191119 | EkoSonic Endovascular Device | Btg International, Inc. | 2019-08-23 |
| K183361 | EkoSonic Endovascular Device with Control Unit 4.0 | Btg International, Inc. | 2019-04-05 |
| K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 | Thrombolex, Inc. | 2019-02-25 |
| K182324 | EkoSonic Endovascular System | Btg International, Inc. | 2018-11-26 |
| K163356 | Pulse* Spray Infusion System, Uni*Fuse Infusion System | AngioDynamics, Inc. | 2017-05-30 |
| K162771 | EkoSonic Endovascular System with Control Unit 4.0 | Btg International, Inc. | 2017-02-24 |
| K170258 | SpeedLyser Infusion Catheter Kit | AngioDynamics, Inc. | 2017-02-21 |
| K162777 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 2016-10-31 |
| K153488 | Occlusion Perfusion Catheter | Advanced Catheter Therapies, Inc. | 2016-02-25 |
| K151554 | Occlusion Perfusion Catheter | Advanced Catheter Therapies, Inc. | 2015-09-15 |
| K140151 | EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT | Btg International, Inc. | 2014-05-21 |
| K130904 | TRELLIS-8 PERIPHERAL INFUSION SYSTEM | Covidien | 2013-10-25 |
| K111705 | EKOSONIC ENDOVASCULAR SYSTEM | Ekos Corporation | 2011-08-03 |
| K083335 | MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM | Omnisonics Medical Technologies | 2008-12-15 |
| K082199 | SPIRALFUSE PERIPHERAL INFUSION SYSTEM | Bacchus Vascular, Inc. | 2008-10-17 |
| K081467 | EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION | Ekos Corp. | 2008-06-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850005115076 | BASHIR™ .035 Endovascular Catheter | THROMBOLEX, INC. | 2023-12-11 |
| 00850005115083 | BASHIR™ S-B .035 Endovascular Catheter | THROMBOLEX, INC. | 2023-12-11 |
| 00850016840158 | EKOS™ | BOSTON SCIENTIFIC CORPORATION | 2023-05-10 |
| 00884450000892 | Fountain® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450011676 | Fountain® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450013434 | Fountain® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450011645 | Fountain® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450011614 | Fountain® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450013441 | Fountain® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450011591 | Fountain® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450011560 | Fountain® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450009994 | Fountain® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450000854 | Fountain® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450000793 | Fountain® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450019290 | Fountain® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450019313 | Fountain® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450000885 | Fountain® | Merit Medical Systems, Inc. | 2016-09-23 |
| 00884450000878 | Fountain® | Merit Medical Systems, Inc. | 2016-09-23 |
| 00884450000861 | Fountain® | Merit Medical Systems, Inc. | 2016-09-23 |
| 00884450011584 | Fountain® | Merit Medical Systems, Inc. | 2016-09-22 |
| 00884450019283 | Fountain® | Merit Medical Systems, Inc. | 2016-09-22 |
| 00884450019276 | Fountain® | Merit Medical Systems, Inc. | 2016-09-22 |
| 00884450012277 | Fountain® | Merit Medical Systems, Inc. | 2016-09-22 |
| 00884450011669 | Fountain® | Merit Medical Systems, Inc. | 2016-09-22 |
| 00884450011652 | Fountain® | Merit Medical Systems, Inc. | 2016-09-22 |
| 00884450011607 | Fountain® | Merit Medical Systems, Inc. | 2016-09-22 |
| 00884450011577 | Fountain® | Merit Medical Systems, Inc. | 2016-09-22 |
| H787128002010 | SpeedLyser | ANGIODYNAMICS, INC. | 2016-09-21 |
| H787128002040 | SpeedLyser | ANGIODYNAMICS, INC. | 2016-09-21 |
| H787128002020 | SpeedLyser | ANGIODYNAMICS, INC. | 2016-09-21 |