COAXIAL DILATOR SET
Device Facts
| Record ID | K000737 |
|---|---|
| Device Name | COAXIAL DILATOR SET |
| Applicant | Xentek Medical, Inc. |
| Product Code | DRE · Cardiovascular |
| Decision Date | Aug 1, 2000 |
| 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.
