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FDA 510(k)

Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)

K-Number: K221661 · 2023-03-03

ApplicantCompression Works, Inc.
Decision Date2023-03-03
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) is a medical device manufactured by Compression Works, Inc.. It received FDA 510(k) clearance on 2023-03-03 under approval number K221661. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Compression Works, Inc.. The 510(k) number is K221661.

When was Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) approved by the FDA?

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

What company makes Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)?

Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) is manufactured by Compression Works, Inc..

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.

Related Clinical Trials

NCT07611968 Prospective Evaluation of Physician Modified Endografts for Aortic Disease NOT_YET_RECRUITING NCT05484115 Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck RECRUITING NCT07573566 Abdominal Aortic Tourniquet Application for Non-Traumatic Out-of-Hospital Cardiac Arrest NOT_YET_RECRUITING NCT06029660 AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion RECRUITING NCT07510451 The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery RECRUITING NCT04252573 Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication ACTIVE_NOT_RECRUITING

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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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