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Updated: Apr 29, 2026

Insertion, Maintenance, and Removal of the Percutaneous Dual Lumen Cannula Right Ventricular Assist Device
Published on: July 20, 2022
Medical devices; general hospital and personal use devices; classification of the intravascular administration set,
Abstract:
The Food and Drug Administration (FDA) is classifying the intravascular administration set, automated air removal system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the intravascular administration set, automated air removal system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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