Cleared Traditional

SAM JUNCTIONAL TOURNIQUET

K131561 · Sam Medical Products · Cardiovascular
Jul 2013
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K131561 is an FDA 510(k) clearance for the SAM JUNCTIONAL TOURNIQUET, a Clamp, Vascular (Class II — Special Controls, product code DXC), submitted by Sam Medical Products (Wilsonville, US). The FDA issued a Cleared decision on July 24, 2013, 55 days after receiving the submission on May 30, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number K131561 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2013
Decision Date July 24, 2013
Days to Decision 55 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXC — Clamp, Vascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4450

Similar Devices — DXC Clamp, Vascular

All 200
Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
K243627 · Arc Trauma, LLC · Dec 2025
Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)
K253070 · Medline Industries, LP · Nov 2025
Radial Compression Device
K232577 · Ningbo Dizegens Medical Science Co.,Ltd · Jan 2024
PICOCLAMP
K230281 · Kono Seisakusho Co., Ltd. · Oct 2023
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
K221661 · Compression Works, Inc. · Mar 2023
VIOLA
K230248 · Vascular Graft Solutions, Ltd. · Feb 2023