21 CFR 870.4370 — Pump, Blood, Cardiopulmonary Bypass, Roller Type
Cardiovascular (CV) · Part 870 Subpart E—Cardiovascular Surgical Devices · § 870.4370
Identification
A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DWB | Pump, Blood, Cardiopulmonary Bypass, Roller Type | 2 | 21 | Life-Sustaining |
