FDA product code QWA: Cardiovascular Delivery Catheter System Positioning And Stabilization Device
QWA is the FDA product code for cardiovascular delivery catheter system positioning and stabilization device. It is a Class I device, regulated under 21 CFR 870.3955 and reviewed by the Cardiovascular panel. Devices under QWA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Cardiovascular Delivery Catheter System Positioning And Stabilization Device |
| Device class | Class I |
| Regulation | 21 CFR 870.3955 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Recalls for QWA devices
openFDA lists no recalls for product code QWA.
Frequently asked questions
What is FDA product code QWA?
QWA is the FDA product code for cardiovascular delivery catheter system positioning and stabilization device. It is a Class I device, regulated under 21 CFR 870.3955 and reviewed by the Cardiovascular panel.
What device class is QWA?
Class I, regulation 21 CFR 870.3955. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QWA
- Run a recall and safety report across every QWA manufacturer
- Watch product code QWA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.