510(k) Report

Devices descending from K122811

5 later devices reach Connector Components with Balance Biosurface through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151523Uncoated Tubing and Connector ComponentsMedtronic, Inc.20154—
+2K171308Tubing PackMedtronic, Inc.201731
+3K171979Tubing PackMedtronic, Inc.2017225
+4K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart Reactors20260—
+4K213540Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia SetQura S.R.L20220—