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510(k) K190102

DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System by Osprey Medical, Inc. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2019
Date Received
January 22, 2019
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.

  • 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)
  • 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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  • K242143 — Angiography Injector (December 23, 2024)
  • K242212 — Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) (August 27, 2024)
  • K241109 — Single-use Sterile High-pressure Angiographic Syringes and Accessories (August 22, 2024)
  • K230668 — Disposable High-pressure Extension Lines (June 14, 2024)
  • K232388 — High Pressure Tubing (November 21, 2023)
  • K211564 — Sterile High-pressure Angiographic Syringes for Single-use (October 19, 2021)
  • K203004 — ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System (December 17, 2020)