510(k) Report

Devices descending from K171251

2 later devices reach 014 Hydrophilic Coated PTA Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200700Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty)…Creagh Medical, Ltd.20201—
+2K211044Sublime Radial Access 018 RX Dilatation CatheterCreagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,20210—