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510(k) K163054

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2017
Date Received
November 1, 2016
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)
  • 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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  • 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)