510(k) Report

Devices descending from K011835

12 later devices reach Cobe Revolution through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193663FloPump 57mL Centrifugal PumpInternational Biophysics Corporation20210—
+1K190650Revolution Centrifugal Blood PumpSorin Group Italia S.R.L.20190—
+1K030154Ideal: System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket…Dideco S.P.A.20033—
+1K030462Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700Cobe Cardiovascular, Inc.200391
+2K192850Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22Qura S.R.L20204—
+2K032040Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump…Dideco S.P.A.200321
+3K202169Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22Qura S.R.L20203—
+3K082412Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model BE-VBT…Mapquet Cardiopulmonary AG20080—
+3K050890Ecc.O SystemDideco S.R.L.20051—
+4K201320Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorQura S.R.L202121
+5K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)Spectrum Medical S.R.L.20250—
+5K233091Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT)…Qura S.R.L20230—