EVERCROSS 0.035 OTW PTA DILATION CATHETER
Device Facts
| Record ID | K103322 |
|---|---|
| Device Name | EVERCROSS 0.035 OTW PTA DILATION CATHETER |
| Applicant | Ev3, Inc. |
| Product Code | LIT · Cardiovascular |
| Decision Date | Dec 6, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
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.
