Cardiovascular Delivery Catheter System Positioning And Stabilization Device
The cardiovascular delivery catheter system positioning and stabilization device (product code QWA) is a platform device or component thereof used to aid the positioning and stabilization of delivery catheter systems during cardiovascular interventional procedures such as transcatheter valvular interventions. Classified as Class 1 under regulation 870.3955 in the Cardiovascular specialty, it is subject only to general controls, with no requirement for 510(k) or PMA submission. The device provides purely mechanical support with no electrical or robotic components and may be single-use or reusable. It is not an implant and is not life-sustaining.
Research product code QWA in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- QWA
- Device Class
- FDA class 1
- Regulation Number
- 870.3955
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 4
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.