510(k) Report

Devices descending from K931489

2 later devices reach Intherm Radially Expanding Dilating Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972684Innerdyne Radially Expanding Vascular Access SystemInnerdyne, Inc.19971—
+2K980578Innerdyne Radially Expanding Vascular Access System (Heparin Coated)Innerdyne, Inc.19980—