EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026
Device Facts
| Record ID | K010162 |
|---|---|
| Device Name | EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026 |
| Applicant | Micro Therapeutics, Inc. |
| Product Code | MJN · Cardiovascular |
| Decision Date | May 18, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| 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.