510(k) Report

Devices descending from K133607

2 later devices reach V8 Transluminal Bav Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150343V8 Transluminal BAV CatheterIntervalve, Inc.20151—
+2K152150V8 Balloon Aortic Valvuloplasty CatheterIntervalve, Inc.20150—