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510(k) K090286

PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE by Advanced Vascular Dynamics — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2009
Date Received
February 5, 2009
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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  • K093192 — FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE (February 12, 2010)
  • K092503 — RADAR VASCULAR COMPRESSION DEVICES (November 19, 2009)
  • K072167 — COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE (September 6, 2007)
  • K040615 — COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM (June 1, 2004)

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  • K230281 — PICOCLAMP (October 23, 2023)
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  • K221843 — GEM Biover Microvascular Clamps (September 14, 2022)
  • K213531 — TR BAND Radial Compression Device (December 20, 2021)
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