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)
FDA 510(k) K211061 · Thrombolex, Inc.
510(k) numberK211061
Submission
- Device name
- 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)
- Applicant
- Thrombolex, Inc.
New Britain, PA, US - Received
- April 9, 2021
- Decision date
- June 10, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QEY – Mechanical Thrombolysis Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
To mechanically disrupt thrombus and/or debris in the peripheral vasculature.
Other 510(k)s with product code QEY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260149 | Versus Catheter (VS110-9NB)QEY · Special | Liquet Medical, Inc. | 02/17/2026SE |
| K251318 | VariFuse Adjustable Infusion CatheterQEY · Traditional | Argon Medical Devices, Inc. | 01/20/2026SE |
| K241851 | Versus Catheter (VS110-8B)QEY · Traditional | Liquet Medical, Inc. | 11/25/2024SE |
| K231653 | BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular CatheterQEY · Special | Thrombolex, Inc. | 07/03/2023SE |
| K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No.…QEY · Traditional | Thrombolex, Inc. | 04/20/2023SE |
| K220866 | EKOS+ Endovascular DeviceQEY · Special | Boston Scientific | 04/20/2022SE |
| K213422 | EkoSonic Endovascular Device, EKOS+ Endovascular DeviceQEY · Traditional | Boston Scientific Corporation | 12/14/2021SE |
| K211080 | EkoSonic Endovascular DeviceQEY · Traditional | Boston Scientific | 11/19/2021SE |
| K202347 | UNIFUSE Infusion System with Cooper WireQEY · Special | AngioDynamics, Inc. | 09/15/2020SE |
| K200648 | EKOS PE Endovascular Device with Control System 4.0 (CS4.0)QEY · Special | Ekos Corporation | 08/17/2020SE |
More from Ekos Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K231653 | BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular CatheterQEY · Special | 07/03/2023SE |
| K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No.…QEY · Traditional | 04/20/2023SE |
| K193071 | Bashir Plus Endovascular CatheterQEY · Traditional | 12/17/2019SE |
| K192598 | Bashir S-B Endovascular Catheter, Ref. No. 7101QEY · Special | 10/18/2019SE |
| K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200QEY · Traditional | 02/25/2019SE |
Questions and answers
When was 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) cleared by the FDA?
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) (K211061) received a 510(k) decision of Substantially Equivalent on June 10, 2021, 62 days after the submission was received.
What is the product code of K211061?
The FDA product code is QEY – Mechanical Thrombolysis Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.5150.