FDA product code QWA

Cardiovascular Delivery Catheter System Positioning And Stabilization Device

Cardiovascular·Class 1·21 CFR 870.3955
US regulatory classifications
US Product Code (FDA)
QWA
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 870.3955
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Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Cardiovascular Delivery Catheter System Positioning And Stabilization Device is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.