510(k) Report

Devices descending from K082933

5 later devices reach Passeo-35 Pta Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142379Passeo-35 PTA CatheterBiotronik, Inc.20143—
+1K130161Passeo-35Biotronik, Inc.20130—
+2K222065Passeo-35 Xeo Peripheral Dilatation CatheterBiotronik, Inc.20231—
+2K152240Passeo-14 Peripheral Dilatation CatheterBiotronik, Inc.20151—
+3K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…Biotronik, Inc.20250—