Cardiovascular Delivery Catheter System Positioning And Stabilization Device
FDA product code QWA · Class I (low risk) · 21 CFR 870.3955 · Cardiovascular
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.
0510(k) clearances
0PMA approvals
0recalls