510(k) Report

Devices descending from DEN190043

7 later devices reach SafeBreak Vascular through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222791SafeBreak VascularLineus Medical, LLC20222—
+1K212064Orchid Safety Release Valve (TM)Linear Health Sciences, LLC20223—
+2K223486SafeBreak® VascularLineus Medical20231—
+2K230266Orchid Safety Release ValveLinear Health Sciences, LLC20232—
+3K232094Orchid Safety Release ValveTMLinear Health Sciences, LLC20231—
+3K231957SafeBreak® VascularLineus Medical20230—
+4K241415Orchid Safety Release Valve™Linear Health Sciences, LLC20240—