QWA · Cardiovascular Delivery Catheter System Positioning And Stabilization Device

Cardiovascular · 21 CFR 870.3955 · Class 1

Overview

Product CodeQWA
Device NameCardiovascular Delivery Catheter System Positioning And Stabilization Device
Regulation21 CFR 870.3955
Device ClassClass 1
Review PanelCardiovascular

Identification

A cardiovascular delivery catheter system positioning and stabilization device is a platform device or a part of a platform device that aids the positioning and stabilization of delivery catheter systems during cardiovascular interventional procedures (e.g., transcatheter valvular interventions). The device only provides mechanical support and does not include any electrical or robotic components. The device may be for single use or reusable.

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