Mistral-Air® Warming System— 510(k) K261437
Substantially EquivalentThe Surgical Company International B.V., doing business as TSC Life
FDA 510(k) clearance K261437 for Mistral-Air® Warming System, Substantially Equivalent on 2026-08-07. Applicant: The Surgical Company International B.V., doing business as TSC Life. Device class: 2.
Summary
The Surgical Company International, doing business as TSC Life, filed the Mistral-Air Warming System under product code DWJ, thermal regulating systems. No model numbers are listed.
Class II, 21 CFR 870.5900. Cardiovascular is both the classification panel and the review panel, and the submission type is Special.
TSC Life filed from Amsterdam, Netherlands. The decision came 99 calendar days after FDA received it (April 30 to August 7, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- The Surgical Company International B.V., doing business as TSC Life
- Product code
- Product code DWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Amsterdam, NL
Recent devices under product code DWJ
view allAdverse events under product code DWJ
product code DWJ- Death
- 7
- Injury
- 679
- Malfunction
- 17,477
- Total
- 18,163
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.