HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123
Device Facts
| Record ID | K011526 |
|---|---|
| Device Name | HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123 |
| Applicant | Micro Therapeutics, Inc. |
| Product Code | MJN · Cardiovascular |
| Decision Date | Jun 14, 2001 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.4450 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.