CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS
Device Facts
| Record ID | K890504 |
|---|---|
| Device Name | CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS |
| Applicant | Gish Biomedical, Inc. |
| Product Code | JOD · Cardiovascular |
| Decision Date | Mar 10, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4270 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary bypass cardiotomy suction line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (a blood clot or a piece of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. This device is intended for use in the cardiotomy suction line.
