ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM
Device Facts
| Record ID | K912019 |
|---|---|
| Device Name | ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM |
| Applicant | Gish Biomedical, Inc. |
| Product Code | CAC · Anesthesiology |
| Decision Date | Oct 8, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5830 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.
