510(k) K260130

Device
Willow 18 Guidewire
Applicant
Arbor Endovascular, LLC
510(k) number
K260130
Product code
MOF
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-13
Date received
2026-01-16
Regulation
870.1330
Classification name
Guide, Wire, Catheter, Neurovasculature
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Kathy Tansey
Address
2345 Bering Dr. San Jose CA US 95131 95131

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
00850076777333Willow 18 GuidewireArbor Endovascular LLC2026-03-16
00850076777326Willow 18 GuidewireArbor Endovascular LLC2026-03-16

Other 510(k) Records For Product Code MOF

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K260537Willow 24 GuidewireArbor Endovascular, LLC2026-03-19
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K244061X-Wire GuidewireImperative Care, Inc.2025-08-26
K2437560.014” Willow GuidewireArbor Endovascular, LLC2025-07-17
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K243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus GuidewireScientia Vascular, Inc.2025-04-01
K240871Synxess Neurovascular GuidewireEnlight Medical Technologies (Shenzhen) Co., Ltd.2024-11-18
K233791Drivewire 24 GuidewireRapid-Medical , Ltd.2024-07-11
K231954Aristotle 18 Guidewire; Aristotle 24 GuidewireScientia Vascular, Inc.2023-08-01
K222690SmartGUIDE deflectable hydrophilic guidewireArtiria Medical SA2023-04-24
K220398Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 GuidewireScientia Vascular, LLC2023-03-10