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FDA 510(k)

Mistral-Air® Warming System

K-Number: K261437 · 2026-08-07

ApplicantThe Surgical Company International B.V., doing business as TSC Life
Decision Date2026-08-07
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Mistral-Air® Warming System is the device name listed in this FDA 510(k) record. The listed applicant is The Surgical Company International B.V., doing business as TSC Life. It received FDA 510(k) clearance on 2026-08-07 under 510(k) number K261437. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mistral-Air® Warming System?

Mistral-Air® Warming System is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is The Surgical Company International B.V., doing business as TSC Life. The 510(k) number is K261437.

When did Mistral-Air® Warming System receive FDA 510(k) clearance?

Mistral-Air® Warming System received FDA 510(k) clearance on 2026-08-07, under 510(k) number K261437.

Who is the listed applicant for Mistral-Air® Warming System?

The FDA 510(k) record lists The Surgical Company International B.V., doing business as TSC Life as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mistral-Air® Warming System?

The FDA product code for Mistral-Air® Warming System is DWJ.

Related Devices (Code: DWJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbHK260903Hot Pink Pad Warming SystemXodus Medical, Inc.K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.K242964Celsi WarmerHadleigh Health TechnologiesK243942Arctic Sun Stat Temperature Management SystemMedivance, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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