K172006

Substantially Equivalent

Alivio Ventricular Catheter and Flusher System (Alivio System)

Applicant: Alcyone Lifesciences, Inc.
Product code: JXG
Advisory panel: Neurology
Date received: 2017-07-03
Decision date: 2017-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lowell, MA, US

Adverse events under product code JXG

product code JXG

Death: 76
Injury: 5,632
Malfunction: 2,230
Other: 4
Total: 7,942

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.