Abdominal Aortic and Junctional Tourniquet (AAJT) Device
510(k) K133029
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK133029 | Date6 Dec 2013 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXC
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4450
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Abdominal Aortic and Junctional Tourniquet (AAJT) Device is a vascular occlusion device designed to control junctional hemorrhage by compressing abdominal vasculature, including the aorta and pelvic arteries. It employs an inflatable wedge-shaped bladder to apply pressure to the lower abdomen, groin, and axilla regions, effectively stopping arterial bleeding in junctional hemorrhage events.
This device is intended for single-use in emergency medical settings and is supplied sterile. It is designed to remain stable during patient movement, ensuring continuous pressure to halt blood flow to the pelvis and lower limbs. The AAJT Device holds an FDA 510(k) clearance under the traditional review pathway, classified under product code DXC and reviewed by the Cardiovascular Advisory Committee.
From the manufacturer
Compression Works is the developer and manufacturer of the Abdominal Aortic and Junctional Tourniquet-Stabilized (AAJT-S) medical device. The company delivers innovative solutions to meet the most pressing and unmet needs of emergency healthcare providers.
Other devices from Compression Works, Inc
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Abdominal Aortic and Junctional Tourniquet (AAJT) Device, and in which medical scenarios would it be used?
The AAJT Device is designed to control junctional hemorrhage by compressing critical blood vessels in the lower abdomen, groin, and axilla regions. It stops arterial bleeding in emergency situations where junctional hemorrhage—such as injuries to the pelvis, aorta, or pelvic arteries—occurs. This makes it particularly useful in trauma settings where rapid hemorrhage control is critical to patient survival.
Is the AAJT Device intended for repeated use, or is it meant to be used only once?
The AAJT Device is explicitly designed for single-use only in emergency medical settings. This ensures sterility and reliability during critical hemorrhage control, as reuse could compromise its effectiveness or introduce infection risks.
How is the AAJT Device supplied, and what does the sterile packaging ensure?
The AAJT Device is supplied sterile in its packaging, meaning it is pre-sterilized and ready for immediate use in emergency scenarios. This ensures that clinicians can apply it without delay, minimizing the risk of infection while controlling junctional hemorrhage.
Does the AAJT Device require any specific storage conditions, and how should it be handled before use?
While the provided data does not specify exact storage conditions, the device’s sterile, single-use design implies it should be stored in a clean, dry environment protected from contamination. It should remain in its original packaging until immediately before use to maintain sterility and functionality.
What regulatory pathway was followed for FDA clearance of the AAJT Device, and which committee reviewed it?
The AAJT Device received FDA clearance through the traditional 510(k) review pathway, classified under product code DXC. It was reviewed by the Cardiovascular Advisory Committee (CV), which evaluates vascular occlusion devices like this one.