FDA.report

510(k) K231293

Device
Drakon™ and Sequre® Microcatheters
Applicant
Accurate Medical Therapeutics
510(k) number
K231293
Product code
DQO
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-01
Date received
2023-05-04
Regulation
870.1200
Classification name
Catheter, Intravascular, Diagnostic
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Osnat Harbater
Address
19 Eli Hurvitz St. Rehovot IL 7608802 7608802

FDA Registration Numbers

Source Documents

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

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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
K230620Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterGentuity, LLC2023-08-08
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