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510(k) K112384

ABDOMINAL TOURNIQUET SYSTEM by Compression Works, LLC — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2011
Date Received
August 18, 2011
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

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  • K230281 — PICOCLAMP (October 23, 2023)
  • K221661 — Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) (March 3, 2023)
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  • K221843 — GEM Biover Microvascular Clamps (September 14, 2022)
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