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510(k) K153141

DyeVert Contrast Modulation System by Osprey Medical, Inc. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2016
Date Received
October 30, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector And Syringe, Angiographic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

Other clearances by Osprey Medical, Inc.

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  • K183267 — DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction Syste (December 20, 2018)
  • K181936 — DyeVert PLUS EZ Contrast Reduction System (October 25, 2018)
  • K171698 — Smart Syringe (July 7, 2017)
  • K171217 — DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System (May 26, 2017)
  • K163054 — DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System (March 8, 2017)
  • K161505 — DyeVert NG Contrast Modulation System (August 3, 2016)
  • K151300 — AVERT Contrast Modulation System (October 15, 2015)
  • K151746 — Dyevert Contrast Modulation System (October 9, 2015)
  • K152218 — AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast (September 21, 2015)

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