Arc Trauma, LLC · Class II · Cleared Dec 31, 2025
| K-number | K243627 |
| Device name | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) |
| Applicant | Arc Trauma, LLC |
| Product code | DXC |
| Device class | Class II |
| Decision date | Dec 31, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.4450 |
The Laryngoscope-Arterial Restriction Clamp (L-ARC) is a vascular clamp designed for military medical personnel to control life-threatening bleeding in the neck and inguinal areas on the battlefield where standard tourniquets cannot be applied. The device can restrict blood flow for up to 4 hours and can also be used to visualize the oropharynx to assist with airway intubation.
The L-ARC has similar technological components to the predicate Combat Ready Clamp (CRoC). Both are vascular clamps designed to apply pressure to restrict arterial blood flow in difficult-to-access anatomical areas.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov