MEDI-TRACE DISP. LINES FOR PHYSIO. PRESS
Device Facts
| Record ID | K801322 |
|---|---|
| Device Name | MEDI-TRACE DISP. LINES FOR PHYSIO. PRESS |
| Applicant | Graphic Controls Corp. |
| Product Code | DQO · Cardiovascular |
| Decision Date | Jun 30, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1200 |
| Device Class | Class 2 |
Regulatory Classification
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.
