BAXTER HANDLE MODEL 1150
Device Facts
| Record ID | K944214 |
|---|---|
| Device Name | BAXTER HANDLE MODEL 1150 |
| Applicant | Baxter Edwards |
| Product Code | DTJ · Cardiovascular |
| Decision Date | Feb 10, 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.
