FDA.report

Willow 14 Guidewire

Primary DI
00850076777098
Brand
Willow 14 Guidewire
Company
Arbor Endovascular LLC
Model
USTA14SO315L
Device description
0.014 Microguidewire, Soft, Pre-shaped, 315cm, 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
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DQXWire, Guide, Catheter

Product Code Classifications

CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Premarket Submissions

SubmissionSupplement
K243756000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850076777098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850076777098008500767770988500767770980850076777098

GMDN Terms

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

Regulatory Flags

DUNS number
134667282
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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

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