510(k) Report

Devices descending from K150634

6 later devices reach AngioSculpt PTA Scoring Baloon Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20240—
+1K232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040…Goodman Co., Ltd.20241—
+1K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific20202—
+2K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.20250—
+2K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterTransit Scientific, LLC20221—
+3K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC20240—