NUI — Ultrasound, Infusion, System Class II
FDA product code NUI covers "Ultrasound, Infusion, System", a Class II medical device regulated under 21 CFR 870.1200. Submissions are reviewed by the Cardiovascular panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NUI
- Device Class
- Class II
- Regulation Number
- 870.1200
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
For regional infusion of contrast materials into selected vessels in the neuro-vasculature. The device may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.