NUI · Ultrasound, Infusion, System
Cardiovascular · 21 CFR 870.1200 · Class 2
Overview
| Product Code | NUI |
|---|---|
| Device Name | Ultrasound, Infusion, System |
| Regulation | 21 CFR 870.1200 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K062508 | NEUROWAVE MICRO-INFUSION SYSTEM | Ekos Corp. | Dec 5, 2006 | SESU |
| K053437 | EKOS MICRO-INFUSION SYSTEM | Ekos Corp. | Jan 6, 2006 | SESE |
| K051225 | EKOS MICRO-INFUSION SYSTEM | Ekos Corp. | Jun 10, 2005 | SESU |
| K041826 | EKOS ULTRASOUND INFUSION SYSTEM | Ekos Corp. | Apr 27, 2005 | SESU |
Top Applicants
- Ekos Corp. — 4 clearances
