Catheter, Percutaneous, Cutting/Scoring

FDA product code PNO · Class II (moderate risk) · 21 CFR 870.1250 · Cardiovascular

To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material

45510(k) clearances
0PMA approvals
3recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K260012UltraScore™ Focused Force PTA BalloonPNO · Special Bard Peripheral Vascular, Inc.02/04/2026SE
K243944Aperta NSE PTA Balloon Dilatation CatheterPNO · Traditional Goodman Co., Ltd.04/22/2025SE
K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterPNO · Traditional Dk Medical Technology Co., Ltd.04/21/2025SE
K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterPNO · Traditional Brosmed Medical Co., Ltd.10/22/2024SE
K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterPNO · Traditional Transit Scientific, LLC06/17/2024SE
K232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040…PNO · Traditional Goodman Co., Ltd.03/28/2024SE
K232207D·Kutting™ PTA Scoring Balloon Dilatation CatheterPNO · Traditional Dk Medical Technology Co., Ltd.03/07/2024SE
K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterPNO · Special Transit Scientific, LLC10/18/2022SE
K220704Serranator PTA Serration Balloon CatheterPNO · Traditional Cagent Vascular, LLC05/04/2022SE
K213728Serranator PTA Serration Balloon CatheterPNO · Special Cagent Vascular, LLC12/15/2021SE
K203437Serranator PTA Serration Balloon CatheterPNO · Special Cagent Vascular, LLC12/22/2020SE
K202187FLEX Vessel Prep SystemPNO · Traditional Venturemed Group, Inc.09/11/2020SE
K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterPNO · Traditional Transit Scientific05/29/2020SE
K193181Serranator PTA Serration Balloon CatheterPNO · Traditional Cagent Vascular, LLC04/15/2020SE
K182713Scoreflex PTA Scoring Balloon CatheterPNO · Traditional Orbusneich Medical Trading, Inc.06/11/2019SE
K172571ULTRASCORE Focused Force PTA BalloonPNO · Special C. R. Bard09/22/2017SE
K163420UltraScore Focused Force PTA BalloonPNO · Traditional Bard Peripheral Vascular, Inc.06/14/2017SE
K163380Serranator Alto PTA Serration Balloon CatheterPNO · Traditional Cagent Vascular, LLC02/13/2017SE
K152789Flex Scoring CatheterPNO · Traditional Venturemed Group05/25/2016SE
K1512532cm Peripheral Cutting Balloon Microsurgical Dilatation CatheterPNO · Special Boston Scientific Limited06/10/2015SE
K150634AngioSculpt PTA Scoring Baloon CathetersPNO · Special Spectranetrics04/08/2015SE
K141322Advance Enforcer 35 Focal Force Pta Balloon CatheterPNO · Traditional Cook Incorporated03/27/2015SE
K142983AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingPNO · Special Angioscore, Inc.03/04/2015SE
K133998Angiosculpt Pta Scoring Balloon with Hydrocross CaotingPNO · Traditional Angioscore, Inc.04/18/2014SE
K122685Angiosculpt Pta Scoring Balloon CatheterPNO · Traditional Angioscore, Inc.01/11/2013SE
K113103Splitwire Percutaneous Transluminal Angioplasty Scoring DevicePNO · Traditional Rex Medical05/22/2012SE
K112182Angiosculpt Pta Scoring Balloon CatheterPNO · Special Angioscore, Inc.08/26/2011SE
K110767Angiosculpt Pta Scoring Balloon CatheterPNO · Special Angioscore, Inc.04/15/2011SE
K103459Vascutrak Pta Dilatation CatheterPNO · Traditional C.R. Bard, Inc.12/13/2010SE
K101735Angiosculpt Pta Scoring Balloon Catheter Model 2039-XXYY, 2155-XXYYPNO · Special Angioscore, Inc.07/14/2010SE
K100303Angiosculpt Pta Scoring Balloon Catheter Model 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYYPNO · Traditional Angioscore, Inc.03/22/2010SE
K091966Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040, 2092-6040, 2105-6040PNO · Special Angioscore, Inc.07/30/2009SE
K082343Vascutrak 2, Models: V14 and V18PNO · Special Ymed, Inc.09/11/2008SE
K082059Angiosculpt Pta Scoring Balloon CatheterPNO · Special Angioscore, Inc.08/11/2008SE
K081220Modification to Angiosculpt Pta Scoring Balloon CatheterPNO · Special Angioscore, Inc.05/28/2008SE
K080151Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039PNO · Traditional Angioscore, Inc.04/25/2008SE
K073025Vascutrak II Pta Dilatation CatheterPNO · Special Thermopeutix, Inc. Dba Ymed, Inc.11/09/2007SE
K072225Angiosculpt Pta Scoring Balloon CatheterPNO · Special Angioscore, Inc.10/12/2007SE
K0709512CM Peripheral Cutting Balloon, Small Peripheral Cutting Balloon with Monorail and…PNO · Traditional Boston Scientific06/04/2007SE
K063657Vascutrak Pta Dilation CatheterPNO · Traditional Ymed, Inc.12/12/2006SE
K062387Small Peripheral Cutting Ballon, Monorail Delivery SystemPNO · Special Boston Scientific10/05/2006SE
K050629Angiosculpt Scoring Balloon CatheterPNO · Traditional Angioscore, Inc.09/02/2005SE
K051254Peripheral Cutting BalloonPNO · Traditional Boston Scientific Ivt06/22/2005SE
K0419932 CM Peripheral Cutting BaloonPNO · Special Boston Scientific Ivt08/16/2004SE
K040155Peripheral Cutting BalloonPNO · Traditional Boston Scientific Corp07/01/2004SE

Recalls

RecallProductFirmInitiated
Z-1758-2019 Class IAdvance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog…Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse… Cook Inc.05/24/2019Terminated
Z-1757-2019 Class IAdvance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number…Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse… Cook Inc.05/24/2019Terminated
Z-1756-2019 Class IAdvance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number…Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse… Cook Inc.05/24/2019Terminated