FDA.reportPublic FDA data

Willow 14 Guidewire

Primary DI
00850076777012
Brand
Willow 14 Guidewire
Company
Arbor Endovascular LLC
Model
USTA14ST215S
Device description
0.014 Microguidewire, Standard, Straight Tip, 215cm, 10cm
Published
2025-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQXWire, Guide, Catheter
MOFGuide, Wire, Catheter, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2
MOFGuide, Wire, Catheter, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243756000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2437560000.014” Willow GuidewireArbor Endovascular, LLC2025-07-17MOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850076777012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850076777012008500767770128500767770120850076777012

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac/peripheral vascular guidewire, single-useA long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
134667282
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850076777326Willow 18 GuidewireUWIL18SO215S2026-03-16
00850076777333Willow 18 GuidewireUWIL18ST215S2026-03-16
00850076777401Cypress 14 GuidewireUCYP14SO200S092026-03-11
00850076777418Cypress 14 GuidewireUCYP14ST200S092026-03-11
00850076777425Cypress 14 GuidewireUCYP14SU200S092026-03-11
00850076777432Cypress 14 GuidewireUCYP14SO315S092026-03-11
00850076777449Cypress 14 GuidewireUCYP14ST315S092026-03-11
00850076777456Cypress 14 GuidewireUCYP14SU315S092026-03-11
00850076777463Cypress 14 GuidewireUCYP14SO200L092026-03-11
00850076777470Cypress 14 GuidewireUCYP14ST200L092026-03-11
00850076777487Cypress 14 GuidewireUCYP14SU200L092026-03-11
00850076777203Willow 14 GuidewireUSTA14SO215S092025-12-05
00850076777210Willow 14 GuidewireUSTA14ST215S092025-12-05
00850076777227Willow 14 GuidewireUSTA14SU215S092025-12-05
00850076777234Willow 14 GuidewireUSTA14SO315S092025-12-05
00850076777241Willow 14 GuidewireUSTA14ST315S092025-12-05
00850076777258Willow 14 GuidewireUSTA14SU315S092025-12-05
00850076777265Willow 14 GuidewireUSTA14SO215L092025-12-05
00850076777272Willow 14 GuidewireUSTA14ST215L092025-12-05
00850076777289Willow 14 GuidewireUSTA14SU215L092025-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971428595857DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595857DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595864DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595864DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595871DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595871DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595888DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595888DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595895DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595895DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595901DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595901DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595918DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595918DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595925DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595925DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
00884450589977SplashWire™Merit Medical Systems, Inc.DQX2026-06-02
07649989542021SmartGUIDE deflectable hydrophilic guidewire Artiria Medical SADQX2026-03-02
07640142811305Guidewire 0.025 6/270cm angled Straub Medical AGDQX2022-06-30
07640142811312SET Aspirex™ S 6F 110cmStraub Medical AGDQX2022-06-30
07640142811329SET Aspirex™ S 6F 135cmStraub Medical AGDQX2022-06-30
07640142811336SET Aspirex™ S 8F 85cmStraub Medical AGDQX2022-06-30
07640142811343SET Aspirex™ S 8F 110cmStraub Medical AGDQX2022-06-30
07640142811350SET Aspirex™ S 10F 110cmStraub Medical AGDQX2022-06-30
07640142811855SET Rotarex™S 6 F x 110 cmStraub Medical AGDQX2022-05-04
07640142811862SET Rotarex™S 6 F x 135 cm Straub Medical AGDQX2022-05-04
07640142811879SET Rotarex™S 8 F x 85 cm Straub Medical AGDQX2022-05-04
07640142811886SET Rotarex™S 8 F x 110 cmStraub Medical AGDQX2022-05-04
10193489078022NAMICMEDLINE INDUSTRIES, INC.DQX2022-02-24
30193489067044NAMICMEDLINE INDUSTRIES, INC.DQX2021-06-03