BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter
FDA 510(k) K231653 · Thrombolex, Inc.
510(k) numberK231653
Submission
- Device name
- BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter
- Applicant
- Thrombolex, Inc.
New Britain, PA, US - Received
- June 6, 2023
- Decision date
- July 3, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| K211061 | BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref.…QEY · Traditional | Thrombolex, Inc. | 06/10/2021SE |
| 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 |
|---|---|---|
| K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No.…QEY · Traditional | 04/20/2023SE |
| K211061 | BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref.…QEY · Traditional | 06/10/2021SE |
| 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 .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter cleared by the FDA?
BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter (K231653) received a 510(k) decision of Substantially Equivalent on July 3, 2023, 27 days after the submission was received.
What is the product code of K231653?
The FDA product code is QEY – Mechanical Thrombolysis Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.5150.