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510(k) K151363

Zephyr Vascular Compression Device by Advanced Vascular Dynamics — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2015
Date Received
May 21, 2015
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 by Advanced Vascular Dynamics

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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)
  • K072167 — COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE (September 6, 2007)
  • K040615 — COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM (June 1, 2004)

Other clearances for product code DXC

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