JOR · Generator, Pulsatile Flow, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4320 · Class 3
Overview
| Product Code | JOR |
|---|---|
| Device Name | Generator, Pulsatile Flow, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4320 |
| Device Class | Class 3 |
| Review Panel | Cardiovascular |
Identification
A cardiopulmonary bypass pulsatile flow generator is an electrically and pneumatically operated device used to create pulsatile blood flow. The device is placed in a cardiopulmonary bypass circuit downstream from the oxygenator.
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
