510(k) Report

Devices descending from K100819

11 later devices reach The Solopath Balloon Expandable Transfemoral Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152194transGlide Expandable IntroducerTransaortic Medical, Inc.20161—
+1K152225Edwards eSheath Introducer SetEdwards Lifesciences20154—
+1K141696Edwards Esheath Introducer SetEdwards Lifesciences20141—
+1K121404Solopath RE-Collapsible Access SystemOnset Medical Corporation20131—
+2K200258Edwards eSheath Introducer SetEdwards Lifesciences20202—
+2K181817transGlideXT Expandable IntroducerTransaortic Medical, Inc.20190Class I
+2K162184Edwards eSheath Introducer SetEdward Lifesciences20163—
+2K152498SoloPath Re-Collapsible Access SystemOnset Medical Corporation20160Class I
+2K152054Confida Adaptive SheathMedtronic, Inc.20150—
+3K244046Edwards eSheath Optima introducer setEdwards Lifesciences20251—
+4K252364Edwards eSheath Optima introducer setEdwards Lifesciences20250—