EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR
Device Facts
| Record ID | K880052 |
|---|---|
| Device Name | EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR |
| Applicant | Baxter Healthcare Corp |
| Product Code | DTJ · Cardiovascular |
| Decision Date | Apr 1, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.3935 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place.
