Ultrasound, Infusion, System
The Ultrasound Infusion System is a cardiovascular device intended for regional infusion of contrast materials into selected vessels in the neurovasculature, providing controlled, regional delivery into selected vessels exclusive of the coronary vasculature. This device combines ultrasound and infusion capabilities for targeted diagnostic or therapeutic applications in neurovascular procedures. It is an FDA Class 2 device regulated under 21 CFR 870.1200 in the Cardiovascular specialty, reviewed by the Neurology panel, with product code NUI, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.
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Basic Information
- Product Code
- NUI
- Device Class
- FDA class 2
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K062508 | NEUROWAVE MICRO-INFUSION SYSTEM | Dec 05, 2006 | Unknown | Ekos Corp. |
| K053437 | EKOS MICRO-INFUSION SYSTEM | Jan 06, 2006 | Substantially Equivalent | Ekos Corp. |
| K051225 | EKOS MICRO-INFUSION SYSTEM | Jun 10, 2005 | Unknown | Ekos Corp. |
| K041826 | EKOS ULTRASOUND INFUSION SYSTEM | Apr 27, 2005 | Unknown | Ekos Corp. |