21 CFR 868.5830 — Apparatus, Autotransfusion
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5830
Identification
An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CAC | Apparatus, Autotransfusion | 2 | 195 | Life-Sustaining |