510(k) Report

Devices descending from K934901

6 later devices reach Tear-Away Sheath Introducer Set with Integral Hemostasis Valve through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143255Prelude SNAP Splittable Sheath IntroducerMerit Medical Systems, Inc.201514
+1K122084Introducer Set, Model Adelante-S SeriesOscor, Inc.20122Class I
+1K043438Large Bore Splittable Introducer KitThomas Medical Products, Inc.20050Class I
+2K201116Abiomed 23 Fr SheathAbiomed, Inc.20200Class I
+2K192769Impella CP IntroducerAbiomed, Inc.20190Class I
+2K152381Prelude SNAP Splittable Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.201502