510(k) Report

Devices descending from K063313

4 later devices reach Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143570WirionGardia Medical20153—
+2K180023WirionGardia Medical, Ltd.20182—
+3K200198WirionCardiovascular Systems, Inc.20201—
+4K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc.20210Class I