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DXT — Injector And Syringe, Angiographic Class II

FDA Device Classification

Classification Details

Product Code
DXT
Device Class
Class II
Regulation Number
870.1650
Submission Type
Review Panel
HO
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251788zhuhai dr medical instruments coExtension tubeMarch 5, 2026
K252891bayer medical careMEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRADFebruary 13, 2026
K244038shandong int medical instruments coHigh Pressure TubingSeptember 5, 2025
K242143shandong int medical instruments coAngiography InjectorDecember 23, 2024
K242212nemoto kyorindo coDisposable Syringe (Kit); Nemoto Disposable Syringe (Kit)August 27, 2024
K241109shenzhen boon medical supply coSingle-use Sterile High-pressure Angiographic Syringes and AccessoriesAugust 22, 2024
K230668precision medical plasticsDisposable High-pressure Extension LinesJune 14, 2024
K232388ningbo dizegens medical science coHigh Pressure TubingNovember 21, 2023
K211564shenzhen boon medical supply coSterile High-pressure Angiographic Syringes for Single-useOctober 19, 2021
K203004acist medical systemsACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery SystemDecember 17, 2020
K201395youwo (guangzhou) medical device coSterile High-pressure Angiographic Syringes for single-useOctober 28, 2020
K192657shenzhen boon medical supply coSterile High-pressure Angiographic Syringes for Single-useAugust 7, 2020
K192370bayer medical careMEDRAD Stellant FLEX CT Injection System with Certegra WorkstationDecember 13, 2019
K193028bayer medical careMEDRAD Mark 7 Arterion Injection SystemDecember 5, 2019
K190102osprey medicalDyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyOctober 17, 2019
K191060acist medical systemsACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT20July 18, 2019
K183267osprey medicalDyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction SysteDecember 20, 2018
K182273bayer medical careMEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD StellNovember 1, 2018
K182276bayer medical careMEDRAD MRXperion MR Injection System and MR Injection System Syringe KitNovember 1, 2018
K181936osprey medicalDyeVert PLUS EZ Contrast Reduction SystemOctober 25, 2018