QEY — Mechanical Thrombolysis Catheter Class II
Classification Details
- Product Code
- QEY
- Device Class
- Class II
- Regulation Number
- 870.5150
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
To mechanically disrupt thrombus and/or debris in the peripheral vasculature.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260149 | liquet medical | Versus Catheter (VS110-9NB) | February 17, 2026 |
| K251318 | argon medical devices | VariFuse Adjustable Infusion Catheter | January 20, 2026 |
| K241851 | liquet medical | Versus Catheter (VS110-8B) | November 25, 2024 |
| K231653 | thrombolex | BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter | July 3, 2023 |
| K222095 | thrombolex | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Re | April 20, 2023 |
| K220866 | boston scientific | EKOS+ Endovascular Device | April 20, 2022 |
| K213422 | boston scientific corporation | EkoSonic Endovascular Device, EKOS+ Endovascular Device | December 14, 2021 |
| K211080 | boston scientific | EkoSonic Endovascular Device | November 19, 2021 |
| K211061 | thrombolex | BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter ( | June 10, 2021 |
| K202347 | angiodynamics | UNIFUSE Infusion System with Cooper Wire | September 15, 2020 |
| K200648 | ekos corporation | EKOS PE Endovascular Device with Control System 4.0 (CS4.0) | August 17, 2020 |
| K192864 | angiodynamics | UNI*FUSE Infusion System with Cooper Wire | June 1, 2020 |
| K193071 | thrombolex | Bashir Plus Endovascular Catheter | December 17, 2019 |
| K192598 | thrombolex | Bashir S-B Endovascular Catheter, Ref. No. 7101 | October 18, 2019 |
| K191119 | btg international | EkoSonic Endovascular Device | August 23, 2019 |
| K183361 | btg international | EkoSonic Endovascular Device with Control Unit 4.0 | April 5, 2019 |
| K183290 | thrombolex | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode | February 25, 2019 |
| K182324 | btg international | EkoSonic Endovascular System | November 26, 2018 |
| K163356 | angiodynamics | Pulse* Spray Infusion System, Uni*Fuse Infusion System | May 30, 2017 |
| K162771 | btg international | EkoSonic Endovascular System with Control Unit 4.0 | February 24, 2017 |