21 CFR 870.4240 — Heat-Exchanger, Cardiopulmonary Bypass
Cardiovascular (CV) · Part 870 Subpart E—Cardiovascular Surgical Devices · § 870.4240
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 2 | 91 | Life-Sustaining |
| OET | Cardioplegia Solution Administration Kit | 2 | 0 |
