510(k) Report

Devices descending from K042175

1 later device reach Heparinase HR Act Control, Model 550-12 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103314Clotrac Heparinase Test Cartidge (HTC) Coagulation ControlMedtronic, Inc.20100—