Lysus Infusion System
FDA 510(k) K050472 · Ekos Corp.
510(k) numberK050472
Submission
- Device name
- Lysus Infusion System
- Applicant
- Ekos Corp.
Bothell, WA, US - Received
- February 24, 2005
- Decision date
- March 11, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRA – Catheter, Steerable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1280
- Specialty
- Cardiovascular
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More from Freudenberg Medical, LLC
| 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 |
| K080392 | EndoWave Infusion SystemQEY · Special | 04/30/2008SE |
| 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 |
Questions and answers
When was Lysus Infusion System cleared by the FDA?
Lysus Infusion System (K050472) received a 510(k) decision of Substantially Equivalent on March 11, 2005, 15 days after the submission was received.
What is the product code of K050472?
The FDA product code is DRA – Catheter, Steerable, a Class II (moderate risk) device regulated under 21 CFR 870.1280.