Zenith Micro Guidewire
K-Number: K252317 · 2026-04-16
Decision Date2026-04-16
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Zenith Micro Guidewire is a medical device manufactured by Suzhou Zenith Vascular SciTech Limited. It received FDA 510(k) clearance on 2026-04-16 under approval 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. It is manufactured by Suzhou Zenith Vascular SciTech Limited. The 510(k) number is K252317.
When was Zenith Micro Guidewire approved by the FDA?
Zenith Micro Guidewire received FDA 510(k) clearance on 2026-04-16, under approval number K252317.
What company makes Zenith Micro Guidewire?
Zenith Micro Guidewire is manufactured by Suzhou Zenith Vascular SciTech Limited.
What is the FDA product code for Zenith Micro Guidewire?
The FDA product code for Zenith Micro Guidewire is MOF.
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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.