510(k) K253168
K253168 is an FDA 510(k) premarket notification submitted by Arbor Endovascular, LLC for the device "0.014 Willow Guidewire". The FDA issued a decision of Substantially Equivalent on November 26, 2025. 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
- November 26, 2025
- Date Received
- September 26, 2025
- 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