510(k) Report

Devices descending from DEN080015

6 later devices reach Nucleus-X PTV Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220881Inoue Balloon aToray Industries, Inc.20220—
+1K133607V8 Transluminal Bav CatheterIntervalve, Inc.201421
+1K132728V8 Transluminal Bav CatheterIntervalve, Inc.20133—
+1K123111V8 Transluminal Bav CatheterIntervalve, Inc.20134—
+2K150343V8 Transluminal BAV CatheterIntervalve, Inc.20151—
+3K152150V8 Balloon Aortic Valvuloplasty CatheterIntervalve, Inc.20150—