FDA.report

510(k) K230620

Device
Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
Applicant
Gentuity, LLC
510(k) number
K230620
Product code
DQO
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-08
Date received
2023-03-06
Regulation
870.1200
Classification name
Catheter, Intravascular, Diagnostic
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Padmini Gagnon
Address
142 N. Rd. Suite G Sudbury MA US 01776 01776

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code DQO

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K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular2026-03-25
K250751DualView CatheterTerumo Corporation2025-07-17
K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC2025-01-31
K242420pNOVUS 21 MicrocatheterPhenox, Ltd.2024-11-12
K233268Impress Angiographic CatheterMerit Medical Systems, Inc.2024-05-22
K233975Zoom 6F Insert CathetersImperative Care, Inc.2024-04-02
K232536Soldier MicrocatheterEmbolx, Inc.2024-02-23
K232573INFINITI™ Ambi Angiographic CatheterCordis US Corp2023-11-21
K231293Drakon™ and Sequre® MicrocathetersAccurate Medical Therapeutics2023-06-01
K230411Dragonfly OpStar™ Imaging CatheterABBOTT MEDICAL2023-04-14
K221279pNOVUS 21 MicrocatheterPhenox, Ltd.2022-11-28
K213666NuCath Wedge Pressure CatheterPfm Medical, Inc.2022-10-06
K221470Langston dual lumen catheterVascular Solutions, LLC2022-06-17
K212977SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbandsCordis Corporation2022-02-17
K211078Progreat LambdaTerumo Clinical Supply Co., Ltd.2021-12-21