FDA.reportPublic FDA data

F-18 Flex

Primary DI
14582233916318
Brand
F-18 Flex
Company
FMD CO., LTD.
Model
F18F04ST190
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
OTC
false
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
14582233916318PackageGS15In Commercial Distribution
04582233916311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1458223391631814582233916318
04582233916311045822339163114582233916311

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length190Centimeter
Outer Diameter0.018Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
696947837
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 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
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

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