FOCUS PC BALLOON DILATATION CATHETER
Device Facts
| Record ID | K954313 |
|---|---|
| Device Name | FOCUS PC BALLOON DILATATION CATHETER |
| Applicant | Cardio-Dynamics, Inc. |
| Product Code | LIT · Cardiovascular |
| Decision Date | Dec 1, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| 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.
