510(k) Report

Devices descending from K203459

2 later devices reach SafeCross Transseptal Puncture and Introducer (TSP/I) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260839Protaryx Transseptal Puncture Device (PTX2-001)Protaryx Medical, Inc.20260—
+1K240600SafeCross Vascular Introducer System (4001)East End Medical I, LLC20240—