FDA 510(k)

Абдоминальный тourniquet аорты и соединения - стабилизированный (AAJT-S)

Номер K: K221661 · 2023-03-03

Дата решения2023-03-03

Код продуктаDXC

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) is the device name listed in this FDA 510(k) record. The listed applicant is Compression Works, Inc.. It received FDA 510(k) clearance on 2023-03-03 under 510(k) number K221661. 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 Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)?

Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) is a medical device that received FDA 510(k) clearance on 2023-03-03. The listed applicant is Compression Works, Inc.. The 510(k) number is K221661.

When did Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) receive FDA 510(k) clearance?

Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) received FDA 510(k) clearance on 2023-03-03, under 510(k) number K221661.

Who is the listed applicant for Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)?

The FDA 510(k) record lists Compression Works, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)?

The FDA product code for Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) 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 K243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLC K253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP

Официальный источник

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