QWA — Cardiovascular Delivery Catheter System Positioning And Stabilization Device Class I
FDA product code QWA covers "Cardiovascular Delivery Catheter System Positioning And Stabilization Device", a Class I medical device regulated under 21 CFR 870.3955. Submissions are reviewed by the Cardiovascular panel.
Classification Details
- Product Code
- QWA
- Device Class
- Class I
- Regulation Number
- 870.3955
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.