510(k) Report

Devices descending from K132030

4 later devices reach Micra Introducer Sheath with Hydrophilic Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140793Nanostim Introducer KitSt. Jude Medical, Inc.20143—
+2K160716The Nanostim Introducer KitSt. Jude Medical, Inc.20162—
+3K211989Aveir IntroducerAbbott Medical20210—
+3K161102Nanostim Introducer KitSt. Jude Medical, Inc.20161—