510(k) Report

Devices descending from K946352

6 later devices reach Lemaitre Valvulotome II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080178Valvulotome by KovenKoven Technology, Inc.20085—
+2K132190Expandable Lemaitre Valvulotome, Over-the-Wire Lemaitre ValvulotomeLeMaitre Vascular, Inc.20134—
+3K250105Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)Aveera Medical, Inc.20250—
+3K221902LimFlow VectorLimFlow, Inc.202211
+3K1400421.5MM Hydro Expandable Lemaitre ValvulotomeLeMaitre Vascular, Inc.201403
+4K260188LimFlow VectorLimFlow, Inc.20260—