510(k) Report

Devices descending from K051984

7 later devices reach Filterwire EZ (2.25 MM - 3.5 MM) Embolic Protection System, Models 20120-190… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061332Filterwire EZ Embolic Protection System (2.25 MM-3.5 MM)Boston Scientific Corp20066—
+2K073523Interceptor Plus Coronary Filter SystemsMedtronic, Inc.20080—
+2K063313Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM)Boston Scientific Corp200646
+3K143570WirionGardia Medical20153—
+4K180023WirionGardia Medical, Ltd.20182—
+5K200198WirionCardiovascular Systems, Inc.20201—
+6K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc.20210Class I