GENTLE HEADER
Device Facts
| Record ID | K902845 |
|---|---|
| Device Name | GENTLE HEADER |
| Applicant | Enhanced Perfusion Systems, Inc. |
| Product Code | DWE · Cardiovascular |
| Decision Date | Dec 3, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4390 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.
