QEY — Mechanical Thrombolysis Catheter Class II
FDA product code QEY covers "Mechanical Thrombolysis Catheter", a Class II medical device regulated under 21 CFR 870.5150. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |