CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100
Device Facts
| Record ID | K870804 |
|---|---|
| Device Name | CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 |
| Applicant | American Bentley |
| Product Code | DTR · Cardiovascular |
| Decision Date | Sep 1, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4240 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.
