K261437
- 510(k) number
- K261437
- Device name
- Mistral-Air® Warming System
- Applicant
- The Surgical Company International B.V., doing business as TSC Life NL
- Product code
- DWJ — System, Thermal Regulating
- Decision date
- 2026-08-07
- Date received
- 2026-04-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K261437.pdf
Official FDA record: K261437
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.