Synxess

Primary DI
06945258302015
Brand
Synxess
Company
Enlight Medical Technologies(Shenzhen) Co., Ltd.
Model
GW1010
Device description
This product is comprised of a stainless steel core wire with distal platinum tungsten coil and proximal stainless steel coil, and includes a shaping mandrel and a torque device. The guidewire distal tip is straight and shapeable. The diameters of the guidewires are listed in the table below. The guidewires are compatible with devices with inner diameters (IDs) specified in the table below. The distal 30 mm of the guidewire tip is radiopaque. Confirm the compatibility of the guidewire diameter with the interventional device before use.For lubricity, the distal 300 mm of the device is coated with hydrophilic coating and the proximal portion of the guidewire is coated with hydrophobic polytetrafluoroethylene (PTFE).The shaping mandrel included with the guidewire can be used to shape the tip of the guidewire as appropriate. When shaping the tip, carefully crimp it while the surface is wet. The torque device included with the guidewire attaches to the proximal end of the wire and functions as a steering guide. Rotation of the torque device facilitates guidewire placement into the target vessel by manipulation of the guidewire tip.
Published
2025-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOFGuide, Wire, Catheter, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240871000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240871000Synxess Neurovascular GuidewireEnlight Medical Technologies (Shenzhen) Co., Ltd.2024-11-18MOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945258302015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945258302015069452583020156945258302015

GMDN Terms#

Term, Definition table
TermDefinition
Neurovascular embolization coilA non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
545380342
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945258302107WaveSelectGW10102025-07-31
06945258302114WaveSelectGW14102025-07-31
06945258302022SynxessGW14102025-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547327159517CHIKAI Nexus petitASAHI INTECC CO., LTD.MOF2026-03-18
04547327159524CHIKAI Nexus petitASAHI INTECC CO., LTD.MOF2026-03-18
04547327159531CHIKAI Nexus petitASAHI INTECC CO., LTD.MOF2026-03-18
00850076777326Willow 18 GuidewireArbor Endovascular LLCMOF2026-03-16
00850076777333Willow 18 GuidewireArbor Endovascular LLCMOF2026-03-16
00850076777401Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777418Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777425Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777432Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777449Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777456Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777463Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777470Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777487Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
07649989542021SmartGUIDE deflectable hydrophilic guidewire Artiria Medical SAMOF2026-03-02
00850076777203Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777210Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777227Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777234Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777241Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777258Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777265Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777272Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777289Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777296Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777302Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777319Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777029Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-01
00850076777005Willow 14 GuidewireArbor Endovascular LLCMOF2025-11-28
00850076777012Willow 14 GuidewireArbor Endovascular LLCMOF2025-11-28