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FDA 510(k)

ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE

K-Number: K133029 · 2013-12-06

ApplicantCompression Works, LLC
Decision Date2013-12-06
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Compression Works, LLC. It received FDA 510(k) clearance on 2013-12-06 under 510(k) number K133029. 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 (AAJT) DEVICE?

ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE is a medical device that received FDA 510(k) clearance on 2013-12-06. The listed applicant is Compression Works, LLC. The 510(k) number is K133029.

When did ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE receive FDA 510(k) clearance?

ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE received FDA 510(k) clearance on 2013-12-06, under 510(k) number K133029.

Who is the listed applicant for ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE?

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

What is the FDA product code for ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE?

The FDA product code for ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE 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.

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Other records listing Compression Works, LLC as applicant

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.

K112384ABDOMINAL TOURNIQUET SYSTEM

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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