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FDA 510(k)

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

K-Number: K243627 · 2025-12-31

ApplicantArc Trauma, LLC
Decision Date2025-12-31
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) is a medical device manufactured by Arc Trauma, LLC. It received FDA 510(k) clearance on 2025-12-31 under approval number K243627. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)?

Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) is a medical device that received FDA 510(k) clearance on 2025-12-31. It is manufactured by Arc Trauma, LLC. The 510(k) number is K243627.

When was Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) approved by the FDA?

Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) received FDA 510(k) clearance on 2025-12-31, under approval number K243627.

What company makes Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)?

Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) is manufactured by Arc Trauma, LLC.

What is the FDA product code for Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)?

The FDA product code for Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) is DXC.

Related Clinical Trials

NCT02746458 Rehabilitation Enhanced by Partial Arterial Inflow Restrictions COMPLETED NCT07568431 Correlation of Cardiac Index Measured by the PRAM Method With NIRS and Lactate Levels in Pediatric Aortic Coarctation Surgery NOT_YET_RECRUITING

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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