Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)— 510(k) K243627
Substantially EquivalentArc 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. Device class: 2.
Clearance details
- Applicant
- Arc Trauma, LLC
- Product code
- Code DXC
- Device class
- Class 2
- Regulation
- 21 CFR 870.4450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jamestown, OH, US
Recent devices under product code DXC
view allAdverse events under product code DXC
product code DXC- Death
- 14
- Injury
- 442
- Malfunction
- 2,209
- Other
- 1
- Total
- 2,666
Source: openFDA MAUDE database, through . 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.