21 CFR 870.4205 — Detector, Bubble, Cardiopulmonary Bypass
Cardiovascular (CV) · Part 870 Subpart E—Cardiovascular Surgical Devices · § 870.4205
Identification
A cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KRL | Detector, Bubble, Cardiopulmonary Bypass | 2 | 14 | 3rd Party |
