EkoSonic Endovascular Device with Control Unit 4.0
FDA 510(k) K183361 · Btg International, Inc.
510(k) numberK183361
Submission
- Device name
- EkoSonic Endovascular Device with Control Unit 4.0
- Applicant
- Btg International, Inc.
Bothell, WA, US - Received
- December 4, 2018
- Decision date
- April 5, 2019
- 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.
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| 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 |
| 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 |
More from AngioDynamics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K191119 | EkoSonic Endovascular DeviceQEY · Special | 08/23/2019SE |
| K182324 | EkoSonic Endovascular SystemQEY · Special | 11/26/2018SE |
| K172035 | EKOS ultrasound EVD Device, EVD Control UnitJXG · Traditional | 03/24/2018SE |
| K162771 | EkoSonic Endovascular System with Control Unit 4.0QEY · Traditional | 02/24/2017SE |
| K140151 | Ekosonic Mach 4 Endovascular Device/Ekosonic Control UnitQEY · Traditional | 05/21/2014SE |
Questions and answers
When was EkoSonic Endovascular Device with Control Unit 4.0 cleared by the FDA?
EkoSonic Endovascular Device with Control Unit 4.0 (K183361) received a 510(k) decision of Substantially Equivalent on April 5, 2019, 122 days after the submission was received.
What is the product code of K183361?
The FDA product code is QEY – Mechanical Thrombolysis Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.5150.