Mistral-Air® Warming System
Device Facts
| Record ID | K261437 |
|---|---|
| Device Name | Mistral-Air® Warming System |
| Applicant | The Surgical Company International B.V., doing business as TSC Life |
| Product Code | DWJ · Cardiovascular |
| Decision Date | Aug 7, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.5900 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.
