STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE
Device Facts
| Record ID | K862116 |
|---|---|
| Device Name | STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE |
| Applicant | Shiley, Inc. |
| Product Code | DWB · Cardiovascular |
| Decision Date | Jul 16, 1986 |
| 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.
