OES · Cardiac Catheterization Kit
Cardiovascular · 21 CFR 870.1200 · Class 2
Overview
| Product Code | OES |
|---|---|
| Device Name | Cardiac Catheterization Kit |
| 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 (0 of 0)
No cleared devices on record.
