21 CFR 870.3925 — Replacement Heart-Valve
Cardiovascular (CV) · Part 870 Subpart D—Cardiovascular Prosthetic Devices · § 870.3925
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.
Classification Rationale
Class III (premarket approval).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DYE | Replacement Heart-Valve | 3 | 8 | Implant |
| PAL | Pulmonic Replacement Heart Valve | f | 0 | Implant, Life-Sustaining |
