FDA.reportPublic FDA data

Cardiac/peripheral vascular guidewire, single-use

Definition
A 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.
GUDID devices
4,269
Last updated
2026-10-17 23:32:20

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00818075010004AristotleSCIENTIA VASCULAR LLC14-200-0012020-02-24
00818075010011AristotleSCIENTIA VASCULAR LLC14-200-0022020-02-24
00818075010028AristotleSCIENTIA VASCULAR LLC14-300-0012020-02-24
00818075010035AristotleSCIENTIA VASCULAR LLC14-300-0022020-02-24
00818075010233AristotleSCIENTIA VASCULAR LLC14-200-0032023-09-25
00818075010240AristotleSCIENTIA VASCULAR LLC14-200-0042023-09-25
00818075010257AristotleSCIENTIA VASCULAR LLC14-300-0032023-09-25
00818075010264AristotleSCIENTIA VASCULAR LLC14-300-0042023-09-25
00850022994005Zurich Pressure Guidewire SystemZURICH MEDICAL INC.Model 1002020-09-21
00818075011261AristotleSCIENTIA VASCULAR LLC016722026-09-21
04251244500429MRWire GuidewireContract Medical International GmbHStraight MR Wire2018-08-07
04251244500436MRWire GuidewireContract Medical International GmbHAngled MR Wire2018-08-07
07613252187004SYNCHRO 14 SStryker CorporationM003135102016-09-21
10705032057004AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.C3515RSA2026-07-29
10705032057011AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.C3515RSS2026-07-29
10705032057028AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.C3515SSA2026-07-29
10705032057035AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.C3518RSA2026-07-29
10705032057042AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.C3518RSS2026-07-29
10705032057059AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.C3518SSA2026-07-29
10705032057066AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.C3526RSA2026-07-29
10705032057073AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.C3526SSA2026-07-29
10705032057080AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.C3526SSS2026-07-29
07613252186939SYNCHRO 14Stryker CorporationM003130202016-09-21
07613252186946SYNCHRO 14Stryker CorporationM003133102016-09-21
07613252186953SYNCHRO 14Stryker CorporationM003133202016-09-21
07613252186960SYNCHRO 14 SStryker CorporationM003134102016-09-21
04547327055741CONFIANZAASAHI INTECC CO., LTD.AG1430902016-09-16
04547327055765CONFIANZAASAHI INTECC CO., LTD.AG1433902016-09-16
04547327082624ASAHI SIONASAHI INTECC CO., LTD.AHW14R001S2016-09-16
04547327086189ASAHI SIONASAHI INTECC CO., LTD.AHW14R001J2016-09-16
04547327086226ASAHI SION blueASAHI INTECC CO., LTD.AHW14R004S2016-09-16
04547327086240ASAHI SION blueASAHI INTECC CO., LTD.AHW14R004J2016-09-16
10886704028376NEUROSCOUTCerenovus, Inc.601-3142016-06-30
10886704028383NEUROSCOUTCerenovus, Inc.601-3152016-06-30
10886704028390NEUROSCOUTCerenovus, Inc.601-4142016-06-30
10886704028406NEUROSCOUTCerenovus, Inc.601-4152016-06-30
04260461060036EMERYGLIDENano4Imaging GmbHEG180089012026-07-23
07290015107426Drivewire 35 GuidewireRAPID MEDICAL LTDDRPP35112026-07-20
06936733736951ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.ST-S351802026-07-10
00816349012570Safari2Lake Region MedicalH74939661L12026-06-25
00816349012587Safari2Lake Region MedicalH74939661S12026-06-25
00816349012594Safari2Lake Region MedicalH74939661XS12026-06-25
00840479402222enableCV Percutaneous Insertion Kit-ArterialENABLECV INC.PIKA2026-06-26
06947358524021Sunmed™ guide wiresSunny Medical Device (Shenzhen) Co., Ltd.J-tip, 0.035"x200cm, PTFE Coated2026-07-07
06947358535454Sunmed™ guide wiresSunny Medical Device (Shenzhen) Co., Ltd.J-tip, 0.035"x145cm, PTFE Coated2026-07-07
06971428595857DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.FG620010222026-07-03
06971428595864DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.FG620010232026-07-03
06971428595871DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.FG620014122026-07-03
06971428595888DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.FG620014222026-07-03
06971428595895DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.FG620014322026-07-03
06971428595901DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.FG620014132026-07-03
06971428595918DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.FG620014232026-07-03
06971428595925DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.FG620014332026-07-03
00613994885005NAMEDTRONIC, INC.0104392016-09-16
00613994885012NAMEDTRONIC, INC.0104402016-09-16
00613994885135NAMEDTRONIC, INC.0088792016-09-16
00613994885197Angiographic Guide WireMEDTRONIC, INC.9948012016-06-18
00613994885203Angiographic Guide WireMEDTRONIC, INC.9948022016-06-18
00613994885210Angiographic Guide WireMEDTRONIC, INC.9948032016-06-18
00613994885227Angiographic Guide WireMEDTRONIC, INC.9948042016-06-18
00613994885234Angiographic Guide WireMEDTRONIC, INC.9948052016-06-18
00613994885241Angiographic Guide WireMEDTRONIC, INC.9948062016-06-18
00613994885258Angiographic Guide WireMEDTRONIC, INC.9948072016-06-18
00613994885265Angiographic Guide WireMEDTRONIC, INC.9948082016-06-18
00613994885272Angiographic Guide WireMEDTRONIC, INC.9948092016-06-18
00613994885289Angiographic Guide WireMEDTRONIC, INC.9948102016-06-18
00613994885401NAMEDTRONIC, INC.0085292016-09-16
00613994885661NAMEDTRONIC, INC.0078732016-09-17
00613994885678NAMEDTRONIC, INC.0078742016-09-16
00613994885685NAMEDTRONIC, INC.0078752016-09-16
00643169357051Confida™MEDTRONIC, INC.GWBC302016-07-23
00643169452282ZINGER® SUPPORTMEDTRONIC, INC.LVZRXT180S2016-07-29
00643169452299ZINGER® SUPPORTMEDTRONIC, INC.LVZRXT180J2016-07-29
00643169452305ZINGER® MEDIUMMEDTRONIC, INC.LVZRMS180S2016-07-29
00643169452312ZINGER® MEDIUMMEDTRONIC, INC.LVZRMS180J2016-08-04
00643169452329ZINGER® LIGHTMEDTRONIC, INC.LVZRLS180S2016-08-04
00643169452336ZINGER® LIGHTMEDTRONIC, INC.LVZRLS180J2016-08-04
00643169452343THUNDER®MEDTRONIC, INC.LVTNDR190S2016-08-04
00643169452473ZINGER® MARKERMEDTRONIC, INC.ZNGRMK300HS2016-06-23
00643169452480ZINGER® MARKERMEDTRONIC, INC.ZNGRMK300HJ2016-07-03