FDA.report

510(k) K221279

Device
pNOVUS 21 Microcatheter
Applicant
Phenox, Ltd.
510(k) number
K221279
Product code
DQO
Decision
Substantially Equivalent (SESE)
Decision date
2022-11-28
Date received
2022-05-03
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
Y
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Sarah Cregg
Address
Kamrick Ct., Ballybrit Business Park Galway IE H91 XY38 H91 XY38

FDA Registration Numbers

Source Documents

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

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K230411Dragonfly OpStar™ Imaging CatheterABBOTT MEDICAL2023-04-14
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