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510(k) K254060

Life Saving Tourniquet by TW Medical — Product Code DXC

K254060 is an FDA 510(k) premarket notification submitted by TW Medical for the device "Life Saving Tourniquet". The FDA issued a decision of Substantially Equivalent on April 3, 2026. 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
April 3, 2026
Date Received
December 17, 2025
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

Other clearances for product code DXC

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  • K252772 — Arc Adjustable Radial Cuff Compression Device (May 22, 2026)
  • K243627 — Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction (December 31, 2025)
  • K253070 — Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRA (November 20, 2025)
  • K232577 — Radial Compression Device (January 18, 2024)
  • K230281 — PICOCLAMP (October 23, 2023)
  • K221661 — Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) (March 3, 2023)
  • K230248 — VIOLA (February 28, 2023)
  • K222182 — Radial Artery Compression Tourniquets (January 4, 2023)
  • K221843 — GEM Biover Microvascular Clamps (September 14, 2022)

FDA data resources