510(k) Report

Devices descending from K132728

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133607V8 Transluminal Bav CatheterIntervalve, Inc.201421
+2K150343V8 Transluminal BAV CatheterIntervalve, Inc.20151—
+3K152150V8 Balloon Aortic Valvuloplasty CatheterIntervalve, Inc.20150—