AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX
Device Facts
| Record ID | K111704 |
|---|---|
| Device Name | AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX |
| Applicant | Avinger, Inc. |
| Product Code | DQY · Cardiovascular |
| Decision Date | Sep 9, 2011 |
| 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.