INTERFACE CARDIOTOMY BLOOD FILTER
Device Facts
| Record ID | K781383 |
|---|---|
| Device Name | INTERFACE CARDIOTOMY BLOOD FILTER |
| Applicant | Medical, Inc. |
| Product Code | JOD · Cardiovascular |
| Decision Date | Sep 27, 1978 |
| 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.
