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FDA 510(k)

Alivio Ventricular Catheter and Flusher System (Alivio System)

K-Number: K172006 · 2017-11-09

ApplicantAlcyone Lifesciences, Inc.
Decision Date2017-11-09
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Alivio Ventricular Catheter and Flusher System (Alivio System) is a medical device manufactured by Alcyone Lifesciences, Inc.. It received FDA 510(k) clearance on 2017-11-09 under approval number K172006. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alivio Ventricular Catheter and Flusher System (Alivio System)?

Alivio Ventricular Catheter and Flusher System (Alivio System) is a medical device that received FDA 510(k) clearance on 2017-11-09. It is manufactured by Alcyone Lifesciences, Inc.. The 510(k) number is K172006.

When was Alivio Ventricular Catheter and Flusher System (Alivio System) approved by the FDA?

Alivio Ventricular Catheter and Flusher System (Alivio System) received FDA 510(k) clearance on 2017-11-09, under approval number K172006.

What company makes Alivio Ventricular Catheter and Flusher System (Alivio System)?

Alivio Ventricular Catheter and Flusher System (Alivio System) is manufactured by Alcyone Lifesciences, Inc..

What is the FDA product code for Alivio Ventricular Catheter and Flusher System (Alivio System)?

The FDA product code for Alivio Ventricular Catheter and Flusher System (Alivio System) is JXG.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT05855135 Assessment of Combined CCM and ICD Device in HFrEF ACTIVE_NOT_RECRUITING

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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