CARBOMEDICS EXENDED MITRAL ROTATOR
Device Facts
| Record ID | K951368 |
|---|---|
| Device Name | CARBOMEDICS EXENDED MITRAL ROTATOR |
| Applicant | Carbomedics, Inc. |
| Product Code | MOP · Cardiovascular |
| Decision Date | Jun 20, 1995 |
| 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.
