510(k) Report

Devices descending from K090914

1 later device reach Axxent Balloon Applicator, Model AB2034, AB2045, AB2056, AB2057E, AB2067E through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.20190—