510(k) Report

Devices descending from K081820

19 later devices reach Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232480ProtekDuo Veno-Venous Cannula SetsCardiacassist, Inc.20230—
+1K171610MC3 QuickFlow Dual Lumen CatheterMc3 Incorporated20173—
+1K142673Bio-Medicus Adult Cannulae and IntroducerMedtronic, Inc.20149—
+1K140999Tandemheart Veno-Venous CannulaCardiacassist, Inc.20147—
+1K130639Elite-I (BI) Dual Lumen Catheter; Elite-I (RA) Dual Lumen Catheter; Elite-I (Bix)Dual…Maquet Cardiopulmonary, AG20130—
+2K201100Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc.20212—
+2K180151MC3 Jugular Dual Lumen CatheterMc3 Incorporated20182—
+2K180453Bio-Medicus Adult Cannulae and IntroducerMedtronic, Inc.20186—
+2K162214Protek Solo 24 Fr Venous Cannula SetCardiacassist, Inc.201601
+2K160257PROTEK Duo 31 Fr. Veno-Venous Cannula SetCardiacassist, Inc.201651
+2K153598Medtronic Bio-Medicus Adult Cannula KitMedtronic, Inc.201611
+3K251831Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc.20260—
+3K240534Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc.20240—
+3K203067Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F…Qura S.R.L20212—
+3K203409MC3 Crescent Jugular Dual Lumen CatheterMc3, Inc.20210—
+3K181150ProtekDuo Mini Veno-Venous Cannula SetCardiacassist, Inc.20181—
+3K180456Bio-Medicus Adult Cannulae KitMedtronic, Inc.201801
+4K221353Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F…Qura S.R.L20221—
+5K241248Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)Spectrum Medical S.R.L.20240—