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510(k) K181936

DyeVert PLUS EZ Contrast Reduction System by Osprey Medical, Inc. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2018
Date Received
July 19, 2018
Clearance Type
Special
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.

  • K190102 — DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, Dy (October 17, 2019)
  • K183267 — DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction Syste (December 20, 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)
  • K153141 — DyeVert Contrast Modulation System (February 4, 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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