FDA 510(k)

Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)

Номер K: K243627 · 2025-12-31

Дата решения2025-12-31

Код продуктаDXC

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) is the device name listed in this FDA 510(k) record. The listed applicant is Arc Trauma, LLC. It received FDA 510(k) clearance on 2025-12-31 under 510(k) number K243627. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)?

Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) is a medical device that received FDA 510(k) clearance on 2025-12-31. The listed applicant is Arc Trauma, LLC. The 510(k) number is K243627.

When did Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) receive FDA 510(k) clearance?

Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) received FDA 510(k) clearance on 2025-12-31, under 510(k) number K243627.

Who is the listed applicant for Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)?

The FDA 510(k) record lists Arc Trauma, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)?

The FDA product code for Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) is DXC.

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: DXC)

K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards Lifesciences K252772Arc Регулируемый Радиальный Жгут Компрессионного УстройстваTz Medical, Inc.K254060Life Saving TourniquetTW Medical K253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP K232577Radial Compression DeviceNingbo Dizegens Medical Science Co.,Ltd

Официальный источник

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