510(k) Report

Devices descending from K192164

1 later device reach Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212667Single Use Guide Sheath Kit-401, K-402Olympus Medical Systems Corp.20210—