FDA.reportPublic FDA data

F-14 Tapered 15

Primary DI
04582233916182
Brand
F-14 Tapered 15
Company
FMD CO., LTD.
Model
F14T15ST300
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
14582233916189PackageGS15In Commercial Distribution
04582233916182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1458223391618914582233916189
04582233916182045822339161824582233916182

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length300Centimeter
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
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
04582233916267F-14 LightF14L02ST2352024-08-20
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
00812013030376Instylla GuidewireINSTYLLA INC.DQX2026-11-04
0086001030638335 Helix GuidewirePIRAEUS MEDICAL INC.DQX2026-10-30
30801902124921ARROWTELEFLEX INCORPORATEDDQX2026-10-13
07540184010127OptoMonitorOpsens IncDQX2026-09-30
07540184020027OptoMonitorOpsens IncDQX2026-09-30
07540184020034OptoMOnitorOpsens IncDQX2026-09-30
07540184020041OptoMonitorOpsens IncDQX2026-09-30
07540184020058OptoMonitorOpsens IncDQX2026-09-30
07540184020065OptoMonitorOpsens IncDQX2026-09-30
07540184020072OptoMonitorOpsens IncDQX2026-09-30
00818075011261AristotleSCIENTIA VASCULAR LLCDQX2026-09-21
10801902226614ARROWTELEFLEX INCORPORATEDDQX2026-08-28
00884450529300SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450529713SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450529829SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450590010SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450631928InQwire® AmplatzMerit Medical Systems, Inc.DQX2026-08-21
00884450731789InQwire®Merit Medical Systems, Inc.DQX2026-08-21
00884450739709InQwire®Merit Medical Systems, Inc.DQX2026-08-21
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQX2026-02-24
00818075010233AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
00818075010240AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
00818075010257AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
00818075010264AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
10801902202984ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902203073ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902210583ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902210590ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902210613ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902210620ARROWTELEFLEX INCORPORATEDDQX2023-06-06