510(k) Report

Devices descending from K091527

2 later devices reach Advance 35LP Low Profile Pta Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141322Advance Enforcer 35 Focal Force Pta Balloon CatheterCook Incorporated20150Class I
+1K132020Advance 34LP Low Profile Pta Balloon Dilatation CatheterCook, Inc.20131—