OET · Cardioplegia Solution Administration Kit
Cardiovascular · 21 CFR 870.4240 · Class 2
Overview
| Product Code | OET |
|---|---|
| Device Name | Cardioplegia Solution Administration Kit |
| Regulation | 21 CFR 870.4240 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
