Willow 12 Guidewire— 510(k) K262424
Substantially EquivalentArbor Endovascular, LLC
FDA 510(k) clearance K262424 for Willow 12 Guidewire, Substantially Equivalent on 2026-08-14. Applicant: Arbor Endovascular, LLC. Device class: 2.
Summary
Arbor Endovascular's Willow 12 Guidewire is filed under product code MOF, neurovasculature catheter guide wires. The record doesn't say what 12 refers to in the name.
Class II, 21 CFR 870.1330. The Neurology review panel handled it as a Special 510(k), though the record lists Cardiovascular as the classification panel.
Arbor filed from San Jose, California. The substantially equivalent decision came 29 calendar days after receipt (July 16 to August 14, 2026).
Clearance details
- Applicant
- Arbor Endovascular, LLC
- Product code
- Product code MOF
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Jose, CA, US
Recent devices under product code MOF
view allMore clearances from Arbor Endovascular, LLC
view allAdverse events under product code MOF
product code MOF- Death
- 6
- Injury
- 137
- Total
- 143
Source: openFDA MAUDE database, through . 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.