510(k) Report

Devices descending from K092014

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121404Solopath RE-Collapsible Access SystemOnset Medical Corporation20131—
+1K100819The Solopath Balloon Expandable Transfemoral IntroducerOnset Medical Corporation201011Class I
+2K152194transGlide Expandable IntroducerTransaortic Medical, Inc.20161—
+2K152498SoloPath Re-Collapsible Access SystemOnset Medical Corporation20160Class I
+2K152225Edwards eSheath Introducer SetEdwards Lifesciences20154—
+2K141696Edwards Esheath Introducer SetEdwards Lifesciences20141—
+3K200258Edwards eSheath Introducer SetEdwards Lifesciences20202—
+3K181817transGlideXT Expandable IntroducerTransaortic Medical, Inc.20190Class I
+3K162184Edwards eSheath Introducer SetEdward Lifesciences20163—
+3K152054Confida Adaptive SheathMedtronic, Inc.20150—
+4K244046Edwards eSheath Optima introducer setEdwards Lifesciences20251—
+5K252364Edwards eSheath Optima introducer setEdwards Lifesciences20250—