FDA 510(k)

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

Numéro K : K243627 · 2025-12-31

Date de décision2025-12-31

Code produitDXC

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Arc Trauma, LLC. The 510(k) number is K243627.

When did Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) receive FDA 510(k) clearance?

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

Who is the listed applicant for Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)?

The FDA 510(k) record lists Arc Trauma, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Source officielle

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