EXTRACORPOREAL HEAT EXCHANGER HE SERIES
Device Facts
| Record ID | K896020 |
|---|---|
| Device Name | EXTRACORPOREAL HEAT EXCHANGER HE SERIES |
| Applicant | Gish Biomedical, Inc. |
| Product Code | DTR · Cardiovascular |
| Decision Date | May 17, 1990 |
| 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.
