MICRO THERAPEUTICS INFUSION CATHETER
Device Facts
| Record ID | K940634 |
|---|---|
| Device Name | MICRO THERAPEUTICS INFUSION CATHETER |
| Applicant | Micro Therapeutics, Inc. |
| Product Code | FOZ · General Hospital |
| Decision Date | Oct 14, 1994 |
| 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.