FDA 510(k)

Fluido® AirGuard System

Номер K: K251733 · 2025-09-04

ЗаявительThe Surgical Company International BV (As Tsc Life)

Дата решения2025-09-04

Код продуктаLGZ

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Fluido® AirGuard System is the device name listed in this FDA 510(k) record. The listed applicant is The Surgical Company International BV (As Tsc Life). It received FDA 510(k) clearance on 2025-09-04 under 510(k) number K251733. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Fluido® AirGuard System?

Fluido® AirGuard System is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is The Surgical Company International BV (As Tsc Life). The 510(k) number is K251733.

When did Fluido® AirGuard System receive FDA 510(k) clearance?

Fluido® AirGuard System received FDA 510(k) clearance on 2025-09-04, under 510(k) number K251733.

Who is the listed applicant for Fluido® AirGuard System?

The FDA 510(k) record lists The Surgical Company International BV (As Tsc Life) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fluido® AirGuard System?

The FDA product code for Fluido® AirGuard System is LGZ.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: LGZ)

K262532NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU Medical K260988°M Warmer System with °M StationMequ A/S K252636Fluido Compact SystemThe Surgical Company International B.V.K232107°M Warmer SystemMequ A/S K211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V.K211800Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid WarmerQuality IN Flow , Ltd.

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