Willow 18 Guidewire— 510(k) K260130
Substantially EquivalentArbor Endovascular, LLC
FDA 510(k) clearance K260130 for Willow 18 Guidewire, Substantially Equivalent on 2026-02-13. Applicant: Arbor Endovascular, LLC. Device class: 2.
Summary
Arbor Endovascular's Willow 18 Guidewire is filed under product code MOF (Guide, Wire, Catheter, Neurovasculature). The record doesn't describe the guidewire beyond its name and that code 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 Endovascular filed from San Jose, California. The decision came 28 calendar days after FDA received it (January 16 to February 13, 2026), and it was substantially equivalent.
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.