PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET
Device Facts
| Record ID | K874927 |
|---|---|
| Device Name | PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET |
| Applicant | Pioneering Technologies, Inc. |
| Product Code | DWC · Cardiovascular |
| Decision Date | Jan 29, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4250 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.
