EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET
Device Facts
| Record ID | K881279 |
|---|---|
| Device Name | EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET |
| Applicant | Baxter Healthcare Corp |
| Product Code | DTI · Cardiovascular |
| Decision Date | May 18, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.3945 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A prosthetic heart valve sizer is a device used to measure the size of the natural valve opening to determine the size of the appropriate replacement heart valve.
