510(k) Report

Devices descending from K170059

2 later devices reach Spectranetics Turbo-Elite Laser Atherectomy Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics20250—
+1K220171NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy CatheterNortheast Scientific, Inc.202201