Cleared Traditional

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

K221661 · Compression Works, Inc. · Cardiovascular

Mar 2023

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K221661 is an FDA 510(k) clearance for the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S), a Clamp, Vascular (Class II — Special Controls, product code DXC), submitted by Compression Works, Inc. (Hoover, US). The FDA issued a Cleared decision on March 3, 2023, 268 days after receiving the submission on June 8, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K221661 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 2022
Decision Date	March 03, 2023
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF