SHEATH/DILATORS
Device Facts
| Record ID | K872724 |
|---|---|
| Device Name | SHEATH/DILATORS |
| Applicant | Med-West, Inc. |
| Product Code | DRE · Cardiovascular |
| Decision Date | Sep 15, 1987 |
| 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.
