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

FDA 510(k) K221661 · Compression Works, Inc.

Substantially Equivalent

510(k) numberK221661

Submission

Device name
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
Applicant
Compression Works, Inc.
Hoover, AL, US
Received
June 8, 2022
Decision date
March 3, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DXC – Clamp, Vascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4450
Specialty
Cardiovascular

Other 510(k)s with product code DXC

510(k)DeviceApplicantDecision
K262086PreludeSYNC™ Radial Compression DeviceDXC · Special Merit Medical Systems, Inc.07/22/2026SE
K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsDXC · Traditional Edwards Lifesciences06/05/2026SE
K252772Arc Adjustable Radial Cuff Compression DeviceDXC · Traditional Tz Medical, Inc.05/22/2026SE
K254060Life Saving TourniquetDXC · Traditional TW Medical04/03/2026SE
K243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp…DXC · Traditional Arc Trauma, LLC12/31/2025SE
K253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)DXC · Traditional Medline Industries, LP11/20/2025SE
K232577Radial Compression DeviceDXC · Traditional Ningbo Dizegens Medical Science Co.,Ltd01/18/2024SE
K230281PicoclampDXC · Traditional Kono Seisakusho Co., Ltd.10/23/2023SE
K230248ViolaDXC · Special Vascular Graft Solutions, Ltd.02/28/2023SE
K222182Radial Artery Compression TourniquetsDXC · Traditional Beijing Demax Medical Technology Co.,Ltd01/04/2023SE

More from Beijing Demax Medical Technology Co.,Ltd

510(k)DeviceDecision
K133029Abdominal Aortic and Junctional Tourniquet (Aajt) DeviceDXC · Traditional 12/06/2013SE
K112384Abdominal Tourniquet SystemDXC · Traditional 10/18/2011SE

Questions and answers

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

Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) (K221661) received a 510(k) decision of Substantially Equivalent on March 3, 2023, 268 days after the submission was received.

What is the product code of K221661?

The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.