MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS
Device Facts
| Record ID | K864155 |
|---|---|
| Device Name | MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS |
| Applicant | American Edwards Laboratories |
| Product Code | DTJ · Cardiovascular |
| Decision Date | Nov 20, 1986 |
| 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.
