MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY
Device Facts
| Record ID | K901815 |
|---|---|
| Device Name | MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY |
| Applicant | Pioneering Technologies, Inc. |
| Product Code | DRE · Cardiovascular |
| Decision Date | Jul 3, 1990 |
| 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.
