0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE
Device Facts
| Record ID | K000632 |
|---|---|
| Device Name | 0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE |
| Applicant | Avitro, LLC |
| Product Code | FOZ · General Hospital |
| Decision Date | Oct 19, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5200 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.
