PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE)
Device Facts
| Record ID | K891786 |
|---|---|
| Device Name | PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) |
| Applicant | Pioneering Technologies, Inc. |
| Product Code | DWP · Cardiovascular |
| Decision Date | Oct 12, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4475 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A surgical vessel dilator is a device used to enlarge or calibrate a vessel.
