510(k) Report

Devices descending from K122012

6 later devices reach Z-Med Z-Med II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253855KardiaPSI Balloon CatheterIntervention Tech, Inc. ; dba Corvention20260—
+1K150343V8 Transluminal BAV CatheterIntervalve, Inc.20151—
+1K142199Ascendra Balloon Aortic Valvaloplasty CatheterEdwards Lifesciences20140—
+1K140241Edwards Transfemoral Balloon CatheterEdwards Lifesciences, LLC20141—
+2K231814ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc.20230—
+2K152150V8 Balloon Aortic Valvuloplasty CatheterIntervalve, Inc.20150—