510(k) Report

Devices descending from K142379

3 later devices reach Passeo-35 PTA Catheter through their predicates, nearest generation first.

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