510(k) Report

Devices descending from K162316

2 later devices reach Pirouette 014 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173621Advocate PTA CatheterMerit Medical Systems, Inc.20171—
+2K192907Advocate PTA CatheterMerit Medical Systems, Inc.20190—