CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE
Device Facts
| Record ID | K942736 |
|---|---|
| Device Name | CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE |
| Applicant | Carbomedics, Inc. |
| Product Code | DTJ · Cardiovascular |
| Decision Date | Jul 6, 1994 |
| 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.
