Willow 12 Guidewire— 510(k) K262424

Name: FDA 510(k) clearance K262424
Creator: U.S. Food and Drug Administration
Published: 2026-08-14

Substantially Equivalent

Arbor Endovascular, LLC

FDA 510(k) clearance K262424 for Willow 12 Guidewire, Substantially Equivalent on 2026-08-14. Applicant: Arbor Endovascular, LLC. Device class: 2.

Clearance details

Applicant: Arbor Endovascular, LLC
Product code: Code MOF
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2026-07-16
Decision date: 2026-08-14
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MOF

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K260751 — 35 Helix Guidewire2026-08-27
K260223 — Aristotle Mini Guidewire2026-08-06
K254006 — Drivewire 35 Guidewire2026-07-17
K253579 — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire2026-04-29
K252317 — Zenith Micro Guidewire2026-04-16

More clearances from Arbor Endovascular, LLC

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K260537 — Willow 24 Guidewire2026-03-19
K260130 — Willow 18 Guidewire2026-02-13
K253168 — 0.014 Willow Guidewire2025-11-26
K243756 — 0.014 Willow Guidewire2025-07-17

Adverse events under product code MOF

product code MOF

Death: 6
Injury: 137
Total: 143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.