ANCURE SHEATH MODEL # 40315, 40320, 40325
Device Facts
| Record ID | K003889 |
|---|---|
| Device Name | ANCURE SHEATH MODEL # 40315, 40320, 40325 |
| Applicant | Guidant Cardiac and Vascular Surgery |
| Product Code | DYB · Cardiovascular |
| Decision Date | Jan 24, 2002 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1340 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.