21 CFR 870.3545 — Ventricular Bypass (Assist) Device
Cardiovascular (CV) · Part 870 Subpart D—Cardiovascular Prosthetic Devices · § 870.3545
Identification
A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body.
Classification Rationale
Class III (premarket approval).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| OKR | Ventricular Bypass (Assist) Device | 3 | 0 | |
| PCK | Pediatric Ventricular Assist Device | f | 0 | Implant, Life-Sustaining |
