MOF

Guide, Wire, Catheter, Neurovasculature

Product code
MOF
Device name
Guide, Wire, Catheter, Neurovasculature
Device class
Class 2
21 CFR
21 CFR 870.1330
Medical specialty
Cardiovascular
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
17
Summaries archived here
17 (direct download)
510(k) clearances (all years, FDA)
44 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (17)

Last three years. Most recent: 2026-08-27.

NumberDecision dateApplicantDevice nameSummary
K2607512026-08-27Piraeus Medical, Inc.35 Helix GuidewirePDF
K2624242026-08-14Arbor Endovascular, LLCWillow 12 GuidewirePDF
K2602232026-08-06Scientia Vascular, Inc.Aristotle Mini GuidewirePDF
K2540062026-07-17Rapid Medical Ltd.Drivewire 35 GuidewirePDF
K2535792026-04-29Scientia Vascular, Inc.Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aris…PDF
K2523172026-04-16Suzhou Zenith Vascular SciTech LimitedZenith Micro GuidewirePDF
K2605372026-03-19Arbor Endovascular, LLCWillow 24 GuidewirePDF
K2521222026-03-16Shanghai Achieva Medical Suzhou Co., L…DCwire Micro-guidewirePDF
K2601302026-02-13Arbor Endovascular, LLCWillow 18 GuidewirePDF
K2520112026-02-02Asahi Intecc Co., Ltd.CHIKAI Nexus petitPDF
K2531682025-11-26Arbor Endovascular, LLC0.014” Willow GuidewirePDF
K2440612025-08-26Imperative Care, Inc.X-Wire GuidewirePDF
K2437562025-07-17Arbor Endovascular, LLC0.014” Willow GuidewirePDF
K2433832025-04-21Asahi Intecc Co., Ltd.CHIKAI Nexus 014PDF
K2439382025-04-01Scientia Vascular, Inc.Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aris…PDF
K2408712024-11-18Enlight Medical Technologies (Shenzhen…Synxess Neurovascular GuidewirePDF
K2337912024-07-11Rapid-Medical , Ltd.Drivewire 24 GuidewirePDF

17 summaries are archived here for direct download.

Official FDA classification page: MOF
Classification and pathway per current FDA publications. Data from openFDA (CC0).