Zenith Micro Guidewire

FDA 510(k) K252317 · Suzhou Zenith Vascular SciTech Limited

Substantially Equivalent

510(k) numberK252317

Submission

Device name
Zenith Micro Guidewire
Applicant
Suzhou Zenith Vascular SciTech Limited
Suzhou, CN
Received
July 25, 2025
Decision date
April 16, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MOF – Guide, Wire, Catheter, Neurovasculature
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1330
Specialty
Cardiovascular

Other 510(k)s with product code MOF

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K26075135 Helix GuidewireMOF · Traditional Piraeus Medical, Inc.08/27/2026SE
K262424Willow 12 GuidewireMOF · Special Arbor Endovascular, LLC08/14/2026SE
K260223Aristotle Mini GuidewireMOF · Traditional Scientia Vascular, Inc.08/06/2026SE
K254006Drivewire 35 GuidewireMOF · Traditional Rapid Medical Ltd.07/17/2026SE
K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…MOF · Traditional Scientia Vascular, Inc.04/29/2026SE
K260537Willow 24 GuidewireMOF · Special Arbor Endovascular, LLC03/19/2026SE
K252122DCwire Micro-guidewireMOF · Traditional Shanghai Achieva Medical Suzhou Co., Ltd.03/16/2026SE
K260130Willow 18 GuidewireMOF · Special Arbor Endovascular, LLC02/13/2026SE
K252011CHIKAI Nexus petitMOF · Traditional Asahi Intecc Co., Ltd.02/02/2026SE
K2531680.014” Willow GuidewireMOF · Special Arbor Endovascular, LLC11/26/2025SE

More from Arbor Endovascular, LLC

510(k)DeviceDecision
K253359Zenith Distal Access Long SheathQJP · Traditional 05/22/2026SE
K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetNRY · Traditional 05/20/2026SE
K243534Micro CatheterKRA · Traditional 07/30/2025SE

Questions and answers

When was Zenith Micro Guidewire cleared by the FDA?

Zenith Micro Guidewire (K252317) received a 510(k) decision of Substantially Equivalent on April 16, 2026, 265 days after the submission was received.

What is the product code of K252317?

The FDA product code is MOF – Guide, Wire, Catheter, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1330.