Cleared Traditional

Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)

K243627 · Arc Trauma, LLC · Cardiovascular

Dec 2025

Decision

401d

Days

Class 2

Risk

About This 510(k) Submission

K243627 is an FDA 510(k) clearance for the Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC), a Clamp, Vascular (Class II — Special Controls, product code DXC), submitted by Arc Trauma, LLC (Jamestown, US). The FDA issued a Cleared decision on December 31, 2025, 401 days after receiving the submission on November 25, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K243627 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 25, 2024
Decision Date	December 31, 2025
Days to Decision	401 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF