510(k) Report

Devices descending from K061332

6 later devices reach Filterwire EZ Embolic Protection System (2.25 MM-3.5 MM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073523Interceptor Plus Coronary Filter SystemsMedtronic, Inc.20080—
+1K063313Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM)Boston Scientific Corp200646
+2K143570WirionGardia Medical20153—
+3K180023WirionGardia Medical, Ltd.20182—
+4K200198WirionCardiovascular Systems, Inc.20201—
+5K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc.20210Class I