FDA.reportPublic FDA data

F-14 Light

Primary DI
04582233916267
Brand
F-14 Light
Company
FMD CO., LTD.
Model
F14L02ST235
Device description
Guidewire
Published
2024-08-20
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212268000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212268000FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXTFMD Co., Ltd.2022-05-27DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14582233916264PackageGS15In Commercial Distribution
04582233916267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1458223391626414582233916264
04582233916267045822339162674582233916267

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length235Centimeter
Outer Diameter0.014Inch

Regulatory Flags#

DUNS number
696947837
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582233916380F-18 FlexF18F04ST4002024-08-20
04582233916359F-14 GentleF14G01ST2352024-08-20
04582233916151F-14 Tapered 3F14T03ST1902024-08-20
04582233916168F-14 Tapered 3F14T03ST3002024-08-20
04582233916175F-14 Tapered 15F14T15ST1902024-08-20
04582233916182F-14 Tapered 15F14T15ST3002024-08-20
04582233916199F-14 Tapered 30F14T30ST1902024-08-20
04582233916212F-18 FloppyF18P06ST1902024-08-20
04582233916229F-18 FloppyF18P06ST3002024-08-20
04582233916236F-18 Hard 15F18H15ST1902024-08-20
04582233916250F-14 LightF14L02ST1902024-08-20
04582233916281F-14 FlexF14F03ST1902024-08-20
04582233916298F-14 FlexF14F03ST2352024-08-20
04582233916311F-18 FlexF18F04ST1902024-08-20
04582233916328F-18 FlexF18F04ST2352024-08-20
04582233916366F-14 GentleF14G01ST3002024-08-20
04582233916373F-14 EXTF14EXTST1652024-08-20
14582233916158F-14 Tapered 3F14T03ST1902024-08-20
14582233916165F-14 Tapered 3F14T03ST3002024-08-20
14582233916172F-14 Tapered 15F14T15ST1902024-08-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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07640142810582SET Rotarex®S 6F 135cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810599SET Rotarex®S 8F 85cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810605SET Rotarex®S 8F 110 cm (Straub Medical®)Straub Medical AGDQX2020-01-31
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