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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 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.

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. 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07573566Abdominal Aortic Tourniquet Application for Non-Traumatic Out-of-Hospital Cardiac ArrestNOT_YET_RECRUITING

Related Devices (Code: DXC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards LifesciencesK252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060Life Saving TourniquetTW MedicalK243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLCK253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP

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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