THE OMNIGUIDE GUIDING CATHETER WITH BALLOON
Device Facts
| Record ID | K945963 |
|---|---|
| Device Name | THE OMNIGUIDE GUIDING CATHETER WITH BALLOON |
| Applicant | Micro Interventional Systems, Inc. |
| Product Code | DQT · Cardiovascular |
| Decision Date | Feb 8, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1370 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A catheter tip occluder is a device that is inserted into certain catheters to prevent flow through one or more orifices.
