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510(k) K072167

COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE by Advanced Vascular Dynamics — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2007
Date Received
August 6, 2007
Clearance Type
Special
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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  • K093192 — FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE (February 12, 2010)
  • K092503 — RADAR VASCULAR COMPRESSION DEVICES (November 19, 2009)
  • K090286 — PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE (March 23, 2009)
  • K040615 — COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM (June 1, 2004)

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  • 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)
  • K213531 — TR BAND Radial Compression Device (December 20, 2021)
  • K210681 — SiteSeal SV (April 6, 2021)