510(k) K243627

Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) by Arc Trauma, LLC — Product Code DXC

K243627 is an FDA 510(k) premarket notification submitted by Arc Trauma, LLC for the device "Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)". The FDA issued a decision of Substantially Equivalent on December 31, 2025. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 2025
Date Received
November 25, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type