510(k) Report

Devices descending from DEN180017

4 later devices reach Quantra Hemostasis Analyzer, QPlus Cartridge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223433Quantra QPlus SystemHemosonics, LLC20222—
+1K201513Quantra QPlus SystemHemosonics, LLC20200—
+2K230461Quantra Hemostasis AnalyzerHemosonics, LLC20231—
+3K232215Quantra Hemostasis AnalyzerHemosonics, LLC20230—