PRO-GUIDE
Device Facts
| Record ID | K911747 |
|---|---|
| Device Name | PRO-GUIDE |
| Applicant | American Interventional Technology |
| Product Code | DQY · Cardiovascular |
| Decision Date | Sep 18, 1991 |
| 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.
