510(k) Report

Devices descending from K152740

8 later devices reach Radifocus Glidewire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253146Hyperdrive 35 GuidewireRapid-Medical, Ltd.20260—
+1K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.20260—
+1K240818R2P Radifocus Glidewire AdvantageTerumo Corporation20240—
+1K232662BNLE Hydrophilic Jacketed Peripheral GuidewireBiomerics Nle20240—
+1K201081AltaTrack equipment, AltaTrack Guidewire, AltaTrack CatheterPhilips Medical System Nederland B.V.20203—
+2K223918AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D HubPhilips Medical Systems Nederland B.V.20232—
+3K233853LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D HubPhilips Medical Systems Nederland B.V.20241—
+4K252645LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D HubPhilips Medical Systems Nederland B.V.20250—