510(k) Report

Devices descending from K233248

2 later devices reach FARADRIVE™ Steerable Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific Corporation20260—
+1K250529Globe Introducer (601-01001)Kardium, Inc.20250—