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510(k) K040615

COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM by Advanced Vascular Dynamics — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2004
Date Received
March 9, 2004
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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  • 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)

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  • K230281 — PICOCLAMP (October 23, 2023)
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  • K221843 — GEM Biover Microvascular Clamps (September 14, 2022)
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  • K210681 — SiteSeal SV (April 6, 2021)