510(k) Report

Devices descending from K150041

4 later devices reach CORA (Coagulation Resonance Analysis) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics Corporation20251—
+1K232018Citrated: K, KH, RTH, FFHHaemonetics Corporation20240—
+1K160502TEG 6s Hemostasis SystemHaemonetics Corporation20170—
+2K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics20250—