CARDIOPLEGIA RECIRCULATION SYS-BL 705/A
Device Facts
| Record ID | K831458 |
|---|---|
| Device Name | CARDIOPLEGIA RECIRCULATION SYS-BL 705/A |
| Applicant | Electromedics, Inc. |
| Product Code | DWB · Cardiovascular |
| Decision Date | Oct 20, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4370 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.