FDA.reportPublic FDA data

WaveSelect

Primary DI
06945258302107
Brand
WaveSelect
Company
Enlight Medical Technologies(Shenzhen) Co., Ltd.
Model
GW1010
Published
2025-07-31
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
06945258302107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945258302107069452583021076945258302107

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945258302114WaveSelectGW14102025-07-31
06945258302015SynxessGW10102025-02-08
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