REUSABLE FOGARTY FLEXIBLE CALIBRATOR
Device Facts
| Record ID | K822687 |
|---|---|
| Device Name | REUSABLE FOGARTY FLEXIBLE CALIBRATOR |
| Applicant | American Edwards Laboratories |
| Product Code | DWP · Cardiovascular |
| Decision Date | Oct 4, 1982 |
| 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.