510(k) Report

Devices descending from K130433

2 later devices reach Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L.20250—
+1K200683INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow…Sorin Group Italia S.R.L.20200—