510(k) Report

Devices descending from K141112

4 later devices reach Sterling Over-the Wire Pta Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192399Infinity Angioplasty Balloon CatheterInfinity Angioplasty Balloon Company, LLC20203—
+2K214038Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc.20222—
+3K241711Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc.20241—
+4K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…Biotronik, Inc.20250—