510(k) Report

Devices descending from K863138

36 later devices reach Terumo Radifocus Guide Wire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.20260—
+1K172187Inno-HydrowireSuzhou Innomed Medical Device Co., Ltd.20180—
+1K170417Glidewire GTTerumo Corporation20171—
+1K160594MRWire Guide WireNano4imaging GmbH20162—
+1K152740Radifocus GlidewireAshitaka Factory of Terumo Corp.20158—
+1K131710Merit Hydrophilic Guide WireMerit Medical Systems, Inc.20135—
+1K121398Charlie Guidewire (Regular), Charlie Guidewire (Stiff)Guidepath Medical, Inc.20120Class I
+1K113162Slidewiretm (Trademark Pending)Acme-Monaco Corp.20121—
+1K092303Merit Laureate Hydrophilic Guide WireMerit Medical Systems, Inc.200996
+1K063372Radifocus Glidewire AdvantageTerumo Medical Corp.20077—
+1K060666Carotid Access KitTerumo Medical Corp.20060—
+1K050873Canalizer Hydrophilic Guide WireMedical Device Technologies, Inc.20051—
+2K253146Hyperdrive 35 GuidewireRapid-Medical, Ltd.20260—
+2K240818R2P Radifocus Glidewire AdvantageTerumo Corporation20240—
+2K240859Glidewire GT-RTerumo Corporation20240—
+2K232662BNLE Hydrophilic Jacketed Peripheral GuidewireBiomerics Nle20240—
+2K213315CROSSLEAD Peripheral Guide WireAsahi Intecc Co., Ltd.20221—
+2K201081AltaTrack equipment, AltaTrack Guidewire, AltaTrack CatheterPhilips Medical System Nederland B.V.20203—
+2K193653Hydrophilic Coating Guide WireSuzhou Hengrui Disheng Medical Co., Ltd.20200—
+2K173423MR Wire Guide Wire Straight, MR Wire Guide Wire AngledNano4imaging GmbH20171—
+2K163004Radifocus Glidewire Advantage TrackAshitaka Factory of Terumo Coporation20170—
+2K141707Ultraskin Hydrophilic Guide WireLepu Medical Technology (Beijing) Co., Ltd.20150—
+2K141295Merit Hydrophilic GuidewireMerit Medical Systems, Inc.20144—
+2K122590Radifocus Glidewire Advantage, Radifocus Glidewire AdvantageTerumo Medical Corporation20131—
+2K120644Merit Hydrophilic Guide WireMerit Medical Systems, Inc.201282
+2K073672Skater Biliary CatheterAngiotech20080—
+3K253262EmeryGlide™ (EG18008901)Nano4imaging GmbH20260—
+3K223918AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D HubPhilips Medical Systems Nederland B.V.20232—
+3K170933Merit Hydrophilic Guide WireMerit Medical Systems, Inc.20173—
+3K130588Merit Hydrophilic Guide WireMerit Medical Systems, Inc.20136—
+3K123609Merit Hydrophilic Guide WireMerit Medical Systems, Inc.20135—
+4K233853LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D HubPhilips Medical Systems Nederland B.V.20241—
+4K201595Merit Hydrophilic Guide WireMerit Medical Systems, Inc.202021
+5K252645LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D HubPhilips Medical Systems Nederland B.V.20250—
+5K251181Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire…Merit Medical Ireland, Ltd.20251—
+6K253847Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)Merit Medical Ireland, Ltd.20260—