510(k) Report

Devices descending from K213917

4 later devices reach QStat Cartridge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240045QStat CartridgeHemosonics, LLC20241—
+1K230461Quantra Hemostasis AnalyzerHemosonics, LLC20231—
+2K251404Quantra QStat CartridgeHemosonics, LLC20250—
+2K232215Quantra Hemostasis AnalyzerHemosonics, LLC20230—