Alivio Ventricular Catheter and Flusher System (Alivio System)
FDA 510(k) K172006 · Alcyone Lifesciences, Inc.
510(k) numberK172006
Submission
- Device name
- Alivio Ventricular Catheter and Flusher System (Alivio System)
- Applicant
- Alcyone Lifesciences, Inc.
Lowell, MA, US - Received
- July 3, 2017
- Decision date
- November 9, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JXG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261004 | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER®…JXG · Traditional | Integra Lifesciences Production Corporation | 06/23/2026SE |
| K251598 | IntellidropJXG · Traditional | Brainspace, Inc. | 12/10/2025SE |
| K250636 | Sophy Mini Monopressure Valve (SM1)JXG · Traditional | Sophysa | 11/28/2025SE |
| K252514 | Evac-MriJXG · Traditional | Phasor Health, LLC | 11/05/2025SESD |
| K243531 | Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyJXG · Traditional | Integra Lifesciences Production Corporation | 08/08/2025SE |
| K243552 | Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer…JXG · Traditional | Integra Lifesciences Production Corporation | 08/06/2025SE |
| K242974 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersJXG · Traditional | Sophysa | 06/20/2025SE |
| K243205 | EvacJXG · Traditional | Phasor Health, LLC | 06/03/2025SE |
| K243676 | Duet External Drainage and Monitoring System (EDMS)JXG · Traditional | Medtronic Neurosurgery | 03/10/2025SE |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetJXG · Traditional | Aesculap, Inc. | 12/16/2024SE |
More from Aesculap, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K150660 | Alcyone MEMS Cannula (AMC) SystemHCD · Traditional | 04/16/2015SE |
Questions and answers
When was Alivio Ventricular Catheter and Flusher System (Alivio System) cleared by the FDA?
Alivio Ventricular Catheter and Flusher System (Alivio System) (K172006) received a 510(k) decision of Substantially Equivalent on November 9, 2017, 129 days after the submission was received.
What is the product code of K172006?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.