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DQO — Catheter, Intravascular, Diagnostic Class II

FDA Device Classification

Classification Details

Product Code
DQO
Device Class
Class II
Regulation Number
870.1200
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250751terumo corporationDualView CatheterJuly 17, 2025
K242966gentuityGentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterJanuary 31, 2025
K242420phenoxpNOVUS 21 MicrocatheterNovember 12, 2024
K233268merit medical systemsImpress Angiographic CatheterMay 22, 2024
K233975imperative careZoom 6F Insert CathetersApril 2, 2024
K232536embolxSoldier MicrocatheterFebruary 23, 2024
K232573cordis usINFINITI™ Ambi Angiographic CatheterNovember 21, 2023
K230620gentuityGentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterAugust 8, 2023
K231293accurate medical therapeuticsDrakon™ and Sequre® MicrocathetersJune 1, 2023
K230411abbott medicalDragonfly OpStar™ Imaging CatheterApril 14, 2023
K221279phenoxpNOVUS 21 MicrocatheterNovember 28, 2022
K213666pfm medicalNuCath Wedge Pressure CatheterOctober 6, 2022
K221470vascular solutionsLangston dual lumen catheterJune 17, 2022
K212977cordis corporationSUPER TORQUE MB Angiographic Catheter with Radiopaque markerbandsFebruary 17, 2022
K211078terumo clinical supply coProgreat LambdaDecember 21, 2021
K203487accurate medical therapeuticsDrakon and Sequre MicrocathetersDecember 11, 2020
K202797accurate medical therapeuticsDrakon and Sequre MicrocathetersOctober 23, 2020
K193647suzhou hengrui disheng medical coSuperpipe Angiographic CatheterJuly 29, 2020
K192267abbott medicalILUMIEN System with AptiVue Software version D.3December 17, 2019
K192122strykerTrevo Trak 21 MicrocatheterNovember 22, 2019