TRAK BACK II
Device Facts
| Record ID | K003938 |
|---|---|
| Device Name | TRAK BACK II |
| Applicant | Jomed, Inc. |
| Product Code | DQO · Cardiovascular |
| Decision Date | Jan 18, 2001 |
| Decision | SESE |
| Submission Type | Special |
| 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.
