510(k) Report

Devices descending from K063234

5 later devices reach ON-Q Introducers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110814Ambit TunnelerSummit Medical Products, Inc.20110—
+1K102594IO-Flex CatheterBaxano, Inc.20110—
+1K102460Ambit Introducer, Ambit Needle, Ambit SheathSummit Medical Products, Inc.20112—
+2K200624Percutaneous IntroducerEpimed International, Inc.20200—
+2K171584B. Braun Tear-Away Introducer NeedleB.Braun Medical, Inc.20170—