FDA.reportPublic FDA data

SV WIRE

Primary DI
10705032056076
Brand
SV WIRE
Company
CORDIS CORPORATION
Model
503658
Catalog number
503658
Device description
PGW .018 SV INTER 180CM ST
Published
2021-01-26
Public version status
Update
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
K963214000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963214000CORDIS ST STEERABLE GUIDEWIRECordis Corp.1996-11-13DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032056073PackageGS15In Commercial Distribution
10705032056076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503205607320705032056073
1070503205607610705032056076

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.

Regulatory Flags#

DUNS number
806136177
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705032019057VISTA BRITE TIP598941P598941P2024-02-23
10705032019170VISTA BRITE TIP598949P598949P2024-02-23
10705032020138VISTA BRITE TIP67004800670048002024-02-23
10705032042956VISTA BRITE TIPSM7497SM74972024-02-23
10705032043069VISTA BRITE TIPSM7540SM75402024-02-23
10705032043144VISTA BRITE TIPSM7548SM75482024-02-23
10705032043151VISTA BRITE TIPSM7549SM75492024-02-23
10705032043434VISTA BRITE TIPSM7596SM75962024-02-23
10705032043779VISTA BRITE TIPSM7652SM76522024-02-23
10705032047050VISTA BRITE TIPSRA0002IGSRA0002IG2024-02-23
10705032047135VISTA BRITE TIPSRA0016IGSRA0016IG2024-02-23
10705032056625ATW Marker Wire Steerable Guidewires595MEJ014595MEJ0142021-01-26
20705032064863VISTA BRITE TIPSM7732SM77322024-02-23
20705032064870VISTA BRITE TIPSM7733SM77332024-02-23
20705032064887VISTA BRITE TIPSM7731SM77312024-02-23
20705032065143VISTA BRITE TIPSM7737SM77372024-02-23
10705032017169VISTA BRITE TIP588823E588823E2016-08-01
10705032017268VISTA BRITE TIP588830E588830E2016-08-01
10705032017299VISTA BRITE TIP588831E588831E2016-08-01
10705032017343VISTA BRITE TIP588834E588834E2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902226430ARROWTELEFLEX INCORPORATEDDQX2026-08-10
10801902206241ARROWTELEFLEX INCORPORATEDDQX2026-08-03
10801902192230ARROWTELEFLEX INCORPORATEDDQX2026-08-01
04547327167215CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167222CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167239CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167246CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167253CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167260CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
10801902190908ARROWTELEFLEX INCORPORATEDDQX2026-07-30
10801902198461ARROWTELEFLEX INCORPORATEDDQX2026-07-30
10705032057004AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057011AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057028AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057035AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057042AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057059AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057066AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057073AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057080AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10801902193237ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902193244ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902195101ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902193251ARROWTELEFLEX INCORPORATEDDQX2026-07-27
10801902193268ARROWTELEFLEX INCORPORATEDDQX2026-07-27
10801902193275ARROWTELEFLEX INCORPORATEDDQX2026-07-27
10801902222357ARROWTELEFLEX INCORPORATEDDQX2026-07-27
04260461060036EMERYGLIDENano4Imaging GmbHDQX2026-07-23
07290015107426Drivewire 35 GuidewireRAPID MEDICAL LTDDQX2026-07-20
06936733736951ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-07-10