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MOF — Guide, Wire, Catheter, Neurovasculature Class II

FDA Device Classification

Classification Details

Product Code
MOF
Device Class
Class II
Regulation Number
870.1330
Submission Type
Review Panel
NE
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252317suzhou zenith vascular scitech limitedZenith Micro GuidewireApril 16, 2026
K260537arbor endovascularWillow 24 GuidewireMarch 19, 2026
K252122shanghai achieva medical suzhou coDCwire Micro-guidewireMarch 16, 2026
K260130arbor endovascularWillow 18 GuidewireFebruary 13, 2026
K252011asahi intecc coCHIKAI Nexus petitFebruary 2, 2026
K253168arbor endovascular0.014” Willow GuidewireNovember 26, 2025
K244061imperative careX-Wire GuidewireAugust 26, 2025
K243756arbor endovascular0.014” Willow GuidewireJuly 17, 2025
K243383asahi intecc coCHIKAI Nexus 014April 21, 2025
K243938scientia vascularAristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom WirApril 1, 2025
K240871enlight medical technologies (shenzhen) coSynxess Neurovascular GuidewireNovember 18, 2024
K233791rapid-medicalDrivewire 24 GuidewireJuly 11, 2024
K231954scientia vascularAristotle 18 Guidewire; Aristotle 24 GuidewireAugust 1, 2023
K222690artiria medicalSmartGUIDE deflectable hydrophilic guidewireApril 24, 2023
K220398scientia vascularAristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 March 10, 2023
K222437scientia vascularAristotle Colossus GuidewireJanuary 26, 2023
K220934terumo medical products (hangzhou) coRADIFOCUS Torque DeviceJune 29, 2022
K200374rapid-medicalColumbus GuidewireDecember 14, 2020
K202522stryker neurovascularSynchro SELECT GuidewireSeptember 25, 2020
K201487microventionTraxcess 7 Mini GuidewireJuly 2, 2020