NOVA SAFE SCALP VEIN BLOOD COLLECTION SET
Device Facts
| Record ID | K090502 |
|---|---|
| Device Name | NOVA SAFE SCALP VEIN BLOOD COLLECTION SET |
| Applicant | U.S. Safety Syringes Co., Inc. |
| Product Code | FOZ · General Hospital |
| Decision Date | Mar 10, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5200 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
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.