ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER
Device Facts
| Record ID | K002676 |
|---|---|
| Device Name | ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER |
| Applicant | Guidant Cardiac and Vascular Surgery |
| Product Code | DYB · Cardiovascular |
| Decision Date | Oct 30, 2000 |
| 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.
