510(k) K260130

Willow 18 Guidewire by Arbor Endovascular, LLC — Product Code MOF

K260130 is an FDA 510(k) premarket notification submitted by Arbor Endovascular, LLC for the device "Willow 18 Guidewire". The FDA issued a decision of Substantially Equivalent on February 13, 2026. The device falls under product code MOF (Guide, Wire, Catheter, Neurovasculature), a Class II device regulated under 21 CFR 870.1330. Arbor Endovascular, LLC has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2026
Date Received
January 16, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Wire, Catheter, Neurovasculature
Device Class
Class II
Regulation Number
870.1330
Review Panel
NE
Submission Type