Class Class II

Abdominal Aortic and Junctional Tourniquet – Stabilized (AAJT-S) (K221661)

K221661 2023-03-03 Traditional
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Description

Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) by Compression Works, Inc., an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK221661
Clearance Date2023-03-03
Clearance TypeTraditional
Product CodeDXC
Regulation Number870.4450

Categories

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Predicate lineage for K221661

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Abdominal Aortic and Junctional Tourniquet – Stabilized (AAJT-S) (K221661) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K133029ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICECompression Works, LLC2013
K131561SAM JUNCTIONAL TOURNIQUETSam Medical Products2013

Trace the full predicate network for K221661

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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