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FDA 510(k)

Zenith Micro Guidewire

K-Number: K252317 · 2026-04-16

ApplicantSuzhou Zenith Vascular SciTech Limited
Decision Date2026-04-16
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Zenith Micro Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Zenith Vascular SciTech Limited. It received FDA 510(k) clearance on 2026-04-16 under 510(k) number K252317. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zenith Micro Guidewire?

Zenith Micro Guidewire is a medical device that received FDA 510(k) clearance on 2026-04-16. The listed applicant is Suzhou Zenith Vascular SciTech Limited. The 510(k) number is K252317.

When did Zenith Micro Guidewire receive FDA 510(k) clearance?

Zenith Micro Guidewire received FDA 510(k) clearance on 2026-04-16, under 510(k) number K252317.

Who is the listed applicant for Zenith Micro Guidewire?

The FDA 510(k) record lists Suzhou Zenith Vascular SciTech Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zenith Micro Guidewire?

The FDA product code for Zenith Micro Guidewire is MOF.

Other records listing Suzhou Zenith Vascular SciTech Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253359Zenith Distal Access Long SheathK252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetK243534Micro Catheter

Related Devices (Code: MOF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262424Willow 12 GuidewireArbor Endovascular, LLCK260223Aristotle Mini GuidewireScientia Vascular, Inc.K254006Drivewire 35 GuidewireRapid Medical Ltd.K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 GuidewireScientia Vascular, Inc.K260537Willow 24 GuidewireArbor Endovascular, LLCK252122DCwire Micro-guidewireShanghai Achieva Medical Suzhou Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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