Ultrasound, Infusion, System

NUI · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1200

Classification

FDA Product Code: NUI
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.1200
Review panel: NE
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 4
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown