510(k) Report

Devices descending from K151153

4 later devices reach Pirouette 018 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173621Advocate PTA CatheterMerit Medical Systems, Inc.20171—
+1K162316Pirouette 014Arravasc, Ltd.20162—
+1K161427Pirouette 035Arravasc Limited20162—
+2K192907Advocate PTA CatheterMerit Medical Systems, Inc.20190—