Abdominal Aortic and Junctional Tourniquet (Aajt) Device

Q: What is the product code of K133029?

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

FDA 510(k) K133029 · Compression Works, LLC

Substantially Equivalent

510(k) numberK133029

Submission

Device name: Abdominal Aortic and Junctional Tourniquet (Aajt) Device
Applicant: Compression Works, LLC
Providence, RI, US
Received: September 26, 2013
Decision date: December 6, 2013
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)	Device	Applicant	Decision
K262086	PreludeSYNC Radial Compression DeviceDXC · Special	Merit Medical Systems, Inc.	07/22/2026SE
K260105	Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsDXC · Traditional	Edwards Lifesciences	06/05/2026SE
K252772	Arc Adjustable Radial Cuff Compression DeviceDXC · Traditional	Tz Medical, Inc.	05/22/2026SE
K254060	Life Saving TourniquetDXC · Traditional	TW Medical	04/03/2026SE
K243627	Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp…DXC · Traditional	Arc Trauma, LLC	12/31/2025SE
K253070	Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)DXC · Traditional	Medline Industries, LP	11/20/2025SE
K232577	Radial Compression DeviceDXC · Traditional	Ningbo Dizegens Medical Science Co.,Ltd	01/18/2024SE
K230281	PicoclampDXC · Traditional	Kono Seisakusho Co., Ltd.	10/23/2023SE
K221661	Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)DXC · Traditional	Compression Works, Inc.	03/03/2023SE
K230248	ViolaDXC · Special	Vascular Graft Solutions, Ltd.	02/28/2023SE

510(k)	Device	Decision
K221661	Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)DXC · Traditional	03/03/2023SE
K112384	Abdominal Tourniquet SystemDXC · Traditional	10/18/2011SE

Questions and answers

When was Abdominal Aortic and Junctional Tourniquet (Aajt) Device cleared by the FDA?

Abdominal Aortic and Junctional Tourniquet (Aajt) Device (K133029) received a 510(k) decision of Substantially Equivalent on December 6, 2013, 71 days after the submission was received.

What is the product code of K133029?

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