Product Code: MOF FDA class 2 21 CFR 870.1330

Guide, Wire, Catheter, Neurovasculature

Cardiovascular

The Neurovasculature Catheter Guide Wire is a cardiovascular device used to navigate and guide catheters through the neurovasculature (blood vessels of the brain and central nervous system) during interventional procedures such as the treatment of cerebral aneurysms or arteriovenous malformations. Classified as FDA Class 2 under 21 CFR 870.1330, it requires 510(k) premarket notification. The product code is MOF, and it is eligible for third-party 510(k) review.

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Basic Information

Product Code: MOF
Device Class: FDA class 2
Regulation Number: 870.1330
Medical Specialty: Cardiovascular
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 40 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253579	Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire	Apr 29, 2026	Substantially Equivalent	Scientia Vascular, Inc.
K252317	Zenith Micro Guidewire	Apr 16, 2026	Substantially Equivalent	Suzhou Zenith Vascular SciTech Limited
K260537	Willow 24 Guidewire	Mar 19, 2026	Substantially Equivalent	Arbor Endovascular, LLC
K252122	DCwire Micro-guidewire	Mar 16, 2026	Substantially Equivalent	Shanghai Achieva Medical Suzhou Co., Ltd.
K260130	Willow 18 Guidewire	Feb 13, 2026	Substantially Equivalent	Arbor Endovascular, LLC
K252011	CHIKAI Nexus petit	Feb 02, 2026	Substantially Equivalent	Asahi Intecc Co., Ltd.
K253168	0.014 Willow Guidewire	Nov 26, 2025	Substantially Equivalent	Arbor Endovascular, LLC
K244061	X-Wire Guidewire	Aug 26, 2025	Substantially Equivalent	Imperative Care, Inc.
K243756	0.014 Willow Guidewire	Jul 17, 2025	Substantially Equivalent	Arbor Endovascular, LLC
K243383	CHIKAI Nexus 014	Apr 21, 2025	Substantially Equivalent	Asahi Intecc Co., Ltd.
K243938	Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire	Apr 01, 2025	Substantially Equivalent	Scientia Vascular, Inc.
K240871	Synxess Neurovascular Guidewire	Nov 18, 2024	Substantially Equivalent	Enlight Medical Technologies (Shenzhen) Co., Ltd.
K233791	Drivewire 24 Guidewire	Jul 11, 2024	Substantially Equivalent	Rapid-Medical , Ltd.
K231954	Aristotle 18 Guidewire; Aristotle 24 Guidewire	Aug 01, 2023	Substantially Equivalent	Scientia Vascular, Inc.
K222690	SmartGUIDE deflectable hydrophilic guidewire	Apr 24, 2023	Substantially Equivalent	Artiria Medical SA
K220398	Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire	Mar 10, 2023	Substantially Equivalent	Scientia Vascular, LLC
K222437	Aristotle Colossus Guidewire	Jan 26, 2023	Substantially Equivalent	Scientia Vascular, Inc.
K220934	RADIFOCUS Torque Device	Jun 29, 2022	Substantially Equivalent	Terumo Medical Products (Hangzhou) Co., Ltd.
K200374	Columbus Guidewire	Dec 14, 2020	Substantially Equivalent	Rapid-Medical , Ltd.
K202522	Synchro SELECT Guidewire	Sep 25, 2020	Substantially Equivalent	Stryker Neurovascular
K201487	Traxcess 7 Mini Guidewire	Jul 02, 2020	Substantially Equivalent	MicroVention, Inc.
K200547	Traxcess 14 SELECT Guidewire	Apr 16, 2020	Substantially Equivalent	MicroVention, Inc.
K191714	ASAHI Neurovascular Guide Wire CHIKAI X 014 soft	Jul 26, 2019	Substantially Equivalent	Asahi Intecc Co., Ltd.
K190843	Synchro2 Support Guidewire	May 01, 2019	Substantially Equivalent	Stryker
K183608	Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile	Mar 22, 2019	Substantially Equivalent	Scientia Vascular, LLC
K183070	ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010	Jan 29, 2019	Substantially Equivalent	Asahi Intecc Co., Ltd.
K182337	HYBRID Guidewire	Oct 04, 2018	Substantially Equivalent	Balt USA, LLC
K181828	Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile	Aug 07, 2018	Substantially Equivalent	Scientia Vascular, LLC
K171613	ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip	Jul 01, 2017	Substantially Equivalent	Asahi Intecc Co., Ltd.
K163154	Traxcess 7 Mini XSoft Guidewire	Dec 09, 2016	Substantially Equivalent	MicroVention, Inc.
K161912	ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip	Oct 14, 2016	Substantially Equivalent	Asahi Intecc Co., Ltd.
K161803	Traxcess .007 Mini Guidewire	Sep 30, 2016	Substantially Equivalent	MicroVention, Inc.
K160659	ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)	Apr 07, 2016	Substantially Equivalent	Asahi Intecc Co., Ltd.
K153053	Traxcess Pro 14 Guidewire	Dec 29, 2015	Substantially Equivalent	MicroVention, Inc.
K151825	Viradius Neurowire	Nov 16, 2015	Substantially Equivalent	Mivi Neuroscience, Inc.
K141751	ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR	Jan 30, 2015	Substantially Equivalent	Asahi Intecc Co., Ltd.
K133725	TRAXCESS 14 GUIDEWIRE	Jul 31, 2014	Substantially Equivalent	MicroVention, Inc.
K133625	AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &	Feb 24, 2014	Substantially Equivalent	Codman & Shurtleff, Inc.
K112979	ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE	Dec 01, 2011	Substantially Equivalent	Asahi Intecc Co., Ltd.
K110584	ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE	Aug 22, 2011	Substantially Equivalent	Asahi Intecc Co., Ltd.