BIOSPHERE MEDICAL INFUSION CATHETER
Device Facts
| Record ID | K003105 |
|---|---|
| Device Name | BIOSPHERE MEDICAL INFUSION CATHETER |
| Applicant | Biosphere Medical |
| Product Code | DQO · Cardiovascular |
| Decision Date | May 22, 2001 |
| 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.
