Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)— 510(k) K243627

Substantially Equivalent

Arc Trauma, LLC

FDA 510(k) clearance K243627 for Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC), Substantially Equivalent on 2025-12-31. Applicant: Arc Trauma, LLC.

Clearance details

Applicant: Arc Trauma, LLC
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2024-11-25
Decision date: 2025-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jamestown, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.