POLYSTAN VERTICLUDE BLOOD PUMP
Device Facts
| Record ID | K813035 |
|---|---|
| Device Name | POLYSTAN VERTICLUDE BLOOD PUMP |
| Applicant | Advocacy International, Ltd. |
| Product Code | DWB · Cardiovascular |
| Decision Date | Nov 27, 1981 |
| 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.
