FDA 510(k)

腹主动脉和橋接縊脈 - 稳定型 (AAJT-S)

K 號：K221661 · 2023-03-03

決定日期2023-03-03

產品代碼DXC

諮詢委員會履歷

決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：DXC）

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器材摘要

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相關器械（代碼：DXC）

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