QEY · Mechanical Thrombolysis Catheter
Cardiovascular · 21 CFR 870.5150 · Class 2
Overview
| Product Code | QEY |
|---|---|
| Device Name | Mechanical Thrombolysis Catheter |
| Regulation | 21 CFR 870.5150 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 71)
Showing 20 most recent of 71 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260149 | Versus Catheter (VS110-9NB) | Liquet Medical, Inc. | Feb 17, 2026 | SESE |
| K251318 | VariFuse Adjustable Infusion Catheter | Argon Medical Devices, Inc. | Jan 20, 2026 | SESE |
| K241851 | Versus Catheter (VS110-8B) | Liquet Medical, Inc. | Nov 25, 2024 | SESE |
| K231653 | BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter | Thrombolex, Inc. | Jul 3, 2023 | SESE |
| K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 | Thrombolex, Inc. | Apr 20, 2023 | SESE |
| K220866 | EKOS+ Endovascular Device | Boston Scientific | Apr 20, 2022 | SESE |
| K213422 | EkoSonic Endovascular Device, EKOS+ Endovascular Device | Boston Scientific Corporation | Dec 14, 2021 | SESE |
| K211080 | EkoSonic Endovascular Device | Boston Scientific | Nov 19, 2021 | SESE |
| 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. | Jun 10, 2021 | SESE |
| K202347 | UNIFUSE Infusion System with Cooper Wire | AngioDynamics, Inc. | Sep 15, 2020 | SESE |
| K200648 | EKOS PE Endovascular Device with Control System 4.0 (CS4.0) | Ekos Corporation | Aug 17, 2020 | SESE |
| K192864 | UNI*FUSE Infusion System with Cooper Wire | AngioDynamics, Inc. | Jun 1, 2020 | SESE |
| K193071 | Bashir Plus Endovascular Catheter | Thrombolex, Inc. | Dec 17, 2019 | SESE |
| K192598 | Bashir S-B Endovascular Catheter, Ref. No. 7101 | Thrombolex, Inc. | Oct 18, 2019 | SESE |
| K191119 | EkoSonic Endovascular Device | Btg International, Inc. | Aug 23, 2019 | SESE |
| K183361 | EkoSonic Endovascular Device with Control Unit 4.0 | Btg International, Inc. | Apr 5, 2019 | SESE |
| K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 | Thrombolex, Inc. | Feb 25, 2019 | SESE |
| K182324 | EkoSonic Endovascular System | Btg International, Inc. | Nov 26, 2018 | SESE |
| K163356 | Pulse* Spray Infusion System, Uni*Fuse Infusion System | AngioDynamics, Inc. | May 30, 2017 | SESE |
| K162771 | EkoSonic Endovascular System with Control Unit 4.0 | Btg International, Inc. | Feb 24, 2017 | SESE |
Top Applicants
- Ekos Corp. — 17 clearances
- Bacchus Vascular, Inc. — 7 clearances
- AngioDynamics, Inc. — 6 clearances
- Thrombolex, Inc. — 6 clearances
- Btg International, Inc. — 5 clearances
