510(k) Report

Devices descending from K180007

1 later device reach 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242419018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterCreagh Medical Ltd. Dba Surmodics, Inc.20240—