IONESCU-SHILEY VALVE HOLDER & HANDLE
Device Facts
| Record ID | K813276 |
|---|---|
| Device Name | IONESCU-SHILEY VALVE HOLDER & HANDLE |
| Applicant | Shiley, Inc. |
| Product Code | DTJ · Cardiovascular |
| Decision Date | Dec 10, 1981 |
| 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.
