510(k) Report

Devices descending from K102645

6 later devices reach Willow/Elm Pta Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230191Arise™ UHP Dilatation CatheterCreagh Medical, Ltd.20230—
+1K171251014 Hydrophilic Coated PTA Balloon Dilatation CatheterCreagh Medical20172—
+1K143561ELM PTA Balloon Dilatation CatheterO'Connell Regulatory Consultants, Inc.20150—
+1K113468Elm Pta Ballon Dilatation CatheterCreagh Medical, Ltd.20110—
+2K200700Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty)…Creagh Medical, Ltd.20201—
+3K211044Sublime Radial Access 018 RX Dilatation CatheterCreagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,20210—