EndoWave Infusion System
FDA 510(k) K080392 · Ekos Corp.
510(k) numberK080392
Submission
- Device name
- EndoWave Infusion System
- Applicant
- Ekos Corp.
Bothell, WA, US - Received
- February 13, 2008
- Decision date
- April 30, 2008
- 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 |
| 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 |
|---|---|---|
| K200648 | EKOS PE Endovascular Device with Control System 4.0 (CS4.0)QEY · Special | 08/17/2020SE |
| K111705 | Ekosonic Endovascular SystemQEY · Traditional | 08/03/2011SE |
| K081467 | Ekosonic Endovascular System with Rapid Pulse ModulationQEY · Special | 06/26/2008SE |
| K073166 | Endowave Infusion SystemKRA · Traditional | 04/22/2008SESU |
| K072507 | Endowave Infusion SystemQEY · Special | 10/04/2007SE |
| K071933 | Endowave Infusion SystemQEY · Special | 08/10/2007SE |
| K063620 | Ekos Micro-Infusion SystemQEY · Traditional | 08/06/2007SESU |
| K062508 | Neurowave Micro-Infusion SystemNUI · Special | 12/05/2006SESU |
| K062507 | Micro-Infusion SystemQEY · Special | 11/22/2006SE |
| K060422 | Lysus Infusion SystemQEY · Special | 03/09/2006SE |
Questions and answers
When was EndoWave Infusion System cleared by the FDA?
EndoWave Infusion System (K080392) received a 510(k) decision of Substantially Equivalent on April 30, 2008, 77 days after the submission was received.
What is the product code of K080392?
The FDA product code is QEY – Mechanical Thrombolysis Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.5150.