510(k) K221661

Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) by Compression Works, Inc. — Product Code DXC

K221661 is an FDA 510(k) premarket notification submitted by Compression Works, Inc. for the device "Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)". The FDA issued a decision of Substantially Equivalent on March 3, 2023. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Compression Works, Inc. has at least 2 other 510(k) clearances on record.