510(k) Report

Devices descending from K191717

2 later devices reach Route 92 Medical Sheath System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242376Next Generation Access PlatformBalt USA, LLC20240Class I
+1K2405298F Modified Sheath SystemRoute 92 Medical, Inc.20240—