Cardiovascular Delivery Catheter System Positioning And Stabilization Device
QWA · Class I — Low Risk (general controls) · Cardiovascular · 21 CFR 870.3955
Classification
FDA Product Code
QWA
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 870.3955
Review panel
CV
Medical specialty
Cardiovascular
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.