FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE
Device Facts
| Record ID | K831659 |
|---|---|
| Device Name | FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE |
| Applicant | American Edwards Laboratories |
| Product Code | LIT · Cardiovascular |
| Decision Date | Aug 12, 1983 |
| 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.
