510(k) Report

Devices descending from K140999

7 later devices reach Tandemheart Veno-Venous Cannula through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232480ProtekDuo Veno-Venous Cannula SetsCardiacassist, Inc.20230—
+1K162214Protek Solo 24 Fr Venous Cannula SetCardiacassist, Inc.201601
+1K160257PROTEK Duo 31 Fr. Veno-Venous Cannula SetCardiacassist, Inc.201651
+2K203067Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F…Qura S.R.L20212—
+2K181150ProtekDuo Mini Veno-Venous Cannula SetCardiacassist, Inc.20181—
+3K221353Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F…Qura S.R.L20221—
+4K241248Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)Spectrum Medical S.R.L.20240—