FDA 510(k) Applications for Medical Device Product Code "PNO"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K072225 | ANGIOSCORE, INC. | ANGIOSCULPT PTA SCORING BALLOON CATHETER | 10/12/2007 |
| K082059 | ANGIOSCORE, INC. | ANGIOSCULPT PTA SCORING BALLOON CATHETER | 08/11/2008 |
| K122685 | ANGIOSCORE, INC. | ANGIOSCULPT PTA SCORING BALLOON CATHETER | 01/11/2013 |
| K110767 | ANGIOSCORE, INC. | ANGIOSCULPT PTA SCORING BALLOON CATHETER | 04/15/2011 |
| K112182 | ANGIOSCORE, INC. | ANGIOSCULPT PTA SCORING BALLOON CATHETER | 08/26/2011 |
| K100303 | ANGIOSCORE, INC. | ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY | 03/22/2010 |
| K101735 | ANGIOSCORE, INC. | ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY | 07/14/2010 |
| K142983 | ANGIOSCORE, INC. | AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating | 03/04/2015 |
| K080151 | ANGIOSCORE, INC. | ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039 | 04/25/2008 |
| K091966 | ANGIOSCORE, INC. | ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 | 07/30/2009 |
| K133998 | ANGIOSCORE, INC. | ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING | 04/18/2014 |
| K050629 | ANGIOSCORE, INC. | ANGIOSCULPT SCORING BALLOON CATHETER | 09/02/2005 |
| K081220 | ANGIOSCORE, INC. | MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER | 05/28/2008 |
| K163420 | BARD PERIPHERAL VASCULAR, INC. | UltraScore Focused Force PTA Balloon | 06/14/2017 |
| K070951 | BOSTON SCIENTIFIC | 2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS | 06/04/2007 |
| K062387 | BOSTON SCIENTIFIC | SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM | 10/05/2006 |
| K040155 | BOSTON SCIENTIFIC CORP. | PERIPHERAL CUTTING BALLOON | 07/01/2004 |
| K041993 | BOSTON SCIENTIFIC IVT | 2 CM PERIPHERAL CUTTING BALOON | 08/16/2004 |
| K051254 | BOSTON SCIENTIFIC IVT | PERIPHERAL CUTTING BALLOON | 06/22/2005 |
| K151253 | BOSTON SCIENTIFIC LIMITED | 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter | 06/10/2015 |
| K241478 | BrosMed Medical Co., Ltd. | Tri-Wedge PTA Scoring Balloon Dilatation Catheter | 10/22/2024 |
| K103459 | C. R. BARD, INC. | VASCUTRAK PTA DILATATION CATHETER | 12/13/2010 |
| K172571 | C.R. Bard | ULTRASCORE Focused Force PTA Balloon | 09/22/2017 |
| K163380 | Cagent Vascular, LLC | Serranator Alto PTA Serration Balloon Catheter | 02/13/2017 |
| K193181 | Cagent Vascular, LLC | Serranator PTA Serration Balloon Catheter | 04/15/2020 |
| K203437 | Cagent Vascular, LLC | Serranator PTA Serration Balloon Catheter | 12/22/2020 |
| K213728 | Cagent Vascular, LLC | Serranator PTA Serration Balloon Catheter | 12/15/2021 |
| K220704 | Cagent Vascular, LLC | Serranator PTA Serration Balloon Catheter | 05/04/2022 |
| K141322 | COOK INCORPORATED | ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER | 03/27/2015 |
| K242254 | DK Medical Technology Co., Ltd. | D╖KuttingÖ LL Peripheral Scoring Balloon Dilatation Catheter | 04/21/2025 |
| K232207 | DK Medical Technology Co., Ltd. | D╖KuttingÖ PTA Scoring Balloon Dilatation Catheter | 03/07/2024 |
| K243944 | Goodman Co., Ltd. | Aperta NSE PTA Balloon Dilatation Catheter | 04/22/2025 |
| K232013 | Goodman Co., Ltd. | Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14 | 03/28/2024 |
| K182713 | OrbusNeich Medical Trading, Inc. | Scoreflex PTA Scoring Balloon Catheter | 06/11/2019 |
| K113103 | REX MEDICAL | SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE | 05/22/2012 |
| K150634 | Spectranetrics | AngioSculpt PTA Scoring Baloon Catheters | 04/08/2015 |
| K073025 | THERMOPEUTIX INC. DBA YMED INC. | VASCUTRAK II PTA DILATATION CATHETER | 11/09/2007 |
| K193495 | Transit Scientific | XO Score Percutaneous Transluminal Angioplasty Scoring Catheter | 05/29/2020 |
| K232258 | Transit Scientific, LLC | XO ConstrainÖ Percutaneous Transluminal Angioplasty Constraining Catheter | 06/17/2024 |
| K221986 | Transit Scientific, LLC | XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter | 10/18/2022 |
| K152789 | VENTUREMED GROUP | FLEX SCORING CATHETER | 05/25/2016 |
| K202187 | VentureMed Group, Inc. | FLEX Vessel Prep System | 09/11/2020 |
| K082343 | YMED INC. | VASCUTRAK 2, MODELS: V14 AND V18 | 09/11/2008 |
| K063657 | YMED INC. | VASCUTRAK PTA DILATION CATHETER | 12/12/2006 |
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