BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA
Device Facts
| Record ID | K000570 |
|---|---|
| Device Name | BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA |
| Applicant | Boston Scientific Corp |
| Product Code | LIT · Cardiovascular |
| Decision Date | Apr 13, 2000 |
| 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.
