BIPORE BALLOON DILATION CATHETER
Device Facts
| Record ID | K073318 |
|---|---|
| Device Name | BIPORE BALLOON DILATION CATHETER |
| Applicant | Bipore, Inc. |
| Product Code | LIT · Cardiovascular |
| Decision Date | Jan 16, 2008 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
