510(k) Report

Devices descending from K214038

2 later devices reach Oscar Peripheral Multifunctional Catheter system through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241711Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc.20241—
+2K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…Biotronik, Inc.20250—