QWA
- Product code
- QWA
- Device name
- Cardiovascular Delivery Catheter System Positioning And Stabilization Device
- Device class
- Class 1
- 21 CFR
- 21 CFR 870.3955
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K) Exempt
FDA classification 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.
Official FDA classification page: QWA
Classification and pathway per current FDA publications. Data from openFDA (CC0).