510(k) Report

Devices descending from K202169

3 later devices reach Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201320Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorQura S.R.L202121
+2K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)Spectrum Medical S.R.L.20250—
+2K233091Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT)…Qura S.R.L20230—