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FDA 510(k)

Willow 12 Guidewire

K-Number: K262424 · 2026-08-14

Decision Date2026-08-14
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Willow 12 Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Arbor Endovascular, LLC. It received FDA 510(k) clearance on 2026-08-14 under 510(k) number K262424. 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 Willow 12 Guidewire?

Willow 12 Guidewire is a medical device that received FDA 510(k) clearance on 2026-08-14. The listed applicant is Arbor Endovascular, LLC. The 510(k) number is K262424.

When did Willow 12 Guidewire receive FDA 510(k) clearance?

Willow 12 Guidewire received FDA 510(k) clearance on 2026-08-14, under 510(k) number K262424.

Who is the listed applicant for Willow 12 Guidewire?

The FDA 510(k) record lists Arbor Endovascular, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Willow 12 Guidewire?

The FDA product code for Willow 12 Guidewire is MOF.

Other records listing Arbor Endovascular, LLC 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.

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.

Official Source

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