FDA.report

ASAHI CHIKAI X 010

Primary DI
04547327120432
Brand
ASAHI CHIKAI X 010
Company
ASAHI INTECC CO., LTD.
Model
AIN-CKX-10-200-R
Published
2019-03-29
Public version status
Update
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
MOFGUIDE, WIRE, CATHETER, NEUROVASCULATURE

Product Code Classifications

CodeDeviceSpecialtyClass
MOFGuide, Wire, Catheter, NeurovasculatureCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04547327120432PrimaryGS10
04547327140324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04547327120432045473271204324547327120432
04547327140324045473271403244547327140324

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.

Device Sizes

TypeValueUnit
Length200Centimeter
Outer Diameter0.01Inch

Sterilization Methods

Method

Regulatory Flags

DUNS number
690711189
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
04547327165563ASAHI VelouteVEL105-16SNK2026-02-05
04547327165570ASAHI VelouteVEL125-16SNK2026-02-05
04547327165587ASAHI VelouteVEL150-16SNK2026-02-05
04547327165594ASAHI Veloute C3VEL105-16SNC3K2026-02-05
04547327165600ASAHI Veloute C3VEL125-16SNC3K2026-02-05
04547327165617ASAHI Veloute C3VEL150-16SNC3K2026-02-05
04547327165624ASAHI TellusTLS105-16SNK2026-02-05
04547327165631ASAHI TellusTLS125-16SNK2026-02-05
04547327165648ASAHI TellusTLS150-16SNK2026-02-05
04547327165655ASAHI Tellus C3TLS105-16SNC3K2026-02-05
04547327165662ASAHI Tellus C3TLS125-16SNC3K2026-02-05
04547327165679ASAHI Tellus C3TLS150-16SNC3K2026-02-05
14547327163368CROSSLEAD Pro 018CPR01810S2025-12-15
14547327163375CROSSLEAD Pro 018CPR01810P2025-12-15
14547327163382CROSSLEAD Pro 018CPR01820S2025-12-15
14547327163399CROSSLEAD Pro 018CPR01820P2025-12-15
14547327163405CROSSLEAD Pro 018CPR01823S2025-12-15
14547327163412CROSSLEAD Pro 018CPR01823P2025-12-15
14547327163429CROSSLEAD Pro 018CPR01830S2025-12-15
14547327163436CROSSLEAD Pro 018CPR01830P2025-12-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
00850076777036Willow 14 GuidewireArbor Endovascular LLCMOF2025-11-28
00850076777043Willow 14 GuidewireArbor Endovascular LLCMOF2025-11-28
00850076777050Willow 14 GuidewireArbor Endovascular LLCMOF2025-11-28