510(k) Report

Devices descending from K961780

2 later devices reach Hemodialysis Introducer Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082063Prelude Short Sheath IntroducerMerit Medical Systems, Inc.20081Class I
+2K122190Prelude 7F Short Sheath IntroducerMerit Medical Systems, Inc.20120—