510(k) Report

Devices descending from K201081

3 later devices reach AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223918AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D HubPhilips Medical Systems Nederland B.V.20232—
+2K233853LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D HubPhilips Medical Systems Nederland B.V.20241—
+3K252645LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D HubPhilips Medical Systems Nederland B.V.20250—