CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS
Device Facts
| Record ID | P870077 |
|---|---|
| Device Name | CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS |
| Applicant | Edwards Lifesciences, LLC |
| Product Code | DYE · Cardiovascular |
| Decision Date | Sep 25, 1991 |
| Decision | APWD |
| Regulation | 21 CFR 870.3925 |
| Device Class | Class 3 |
Regulatory Classification
Identification
A replacement heart valve is a device intended to perform the function of any of the heart's natural valves. This device includes valves constructed of prosthetic materials, biologic valves (e.g., porcine valves), or valves constructed of a combination of prosthetic and biologic materials.
