EVT EXPANDABLE SHEATH
Device Facts
| Record ID | K970470 |
|---|---|
| Device Name | EVT EXPANDABLE SHEATH |
| Applicant | Guidant Cardiac and Vascular Surgery |
| Product Code | DRE · Cardiovascular |
| Decision Date | Jul 31, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1310 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.
