510(k) Report

Devices descending from K121083

13 later devices reach True Dilatation Percutaneous Transluminal Valvuloplasty Catheter, 20MM X… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142199Ascendra Balloon Aortic Valvaloplasty CatheterEdwards Lifesciences20140—
+1K140241Edwards Transfemoral Balloon CatheterEdwards Lifesciences, LLC20141—
+1K133569True Dilatation Balloon Valvuloplasty Catheter, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X…Bard Peripheral Vascular, Inc.20139—
+2K231814ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc.20230—
+2K150667True Dilatation Balloon Valvuloplasty CatheterC.R. Bard, Inc.20150—
+2K142083True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc.20153—
+2K141985True BA V Balloon Valvuloplasty CatheterC.R. Bard, Inc.20143—
+3K212588Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV…C.R. Bard, Inc.20222—
+3K152613True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc.20162—
+4K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20241—
+4K172932True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc.20171—
+5K251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20250—
+5K241562OutFlo Aortic Valve Dilatation Balloon CatheterDisa Medinotec20250—