510(k) Report

Devices descending from K190690

1 later device reach INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201916Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M…Sorin Group Italia S.R.L.20200—