MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT
Device Facts
| Record ID | K000659 |
|---|---|
| Device Name | MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT |
| Applicant | Merit Medical Systems, Inc. |
| Product Code | DQO · Cardiovascular |
| Decision Date | Mar 29, 2000 |
| 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.
