| UltraScore™ Focused Force PTA Balloon (K260012) | Bard Peripheral Vascular, Inc. | 2026-02-04 |
| Aperta NSE PTA Balloon Dilatation Catheter (K243944) | Goodman Co., Ltd. | 2025-04-22 |
| D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter (K242254) | Dk Medical Technology Co., Ltd. | 2025-04-21 |
| Tri-Wedge PTA Scoring Balloon Dilatation Catheter (K241478) | Brosmed Medical Co., Ltd. | 2024-10-22 |
| XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter (K232258) | Transit Scientific, LLC | 2024-06-17 |
| 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, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040) (K232013) | Goodman Co., Ltd. | 2024-03-28 |
| D·Kutting™ PTA Scoring Balloon Dilatation Catheter (K232207) | Dk Medical Technology Co., Ltd. | 2024-03-07 |
| XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter (K221986) | Transit Scientific, LLC | 2022-10-18 |
| Serranator PTA Serration Balloon Catheter (K220704) | Cagent Vascular, LLC | 2022-05-04 |
| Serranator PTA Serration Balloon Catheter (K213728) | Cagent Vascular, LLC | 2021-12-15 |
| Serranator PTA Serration Balloon Catheter (K203437) | Cagent Vascular, LLC | 2020-12-22 |
| FLEX Vessel Prep System (K202187) | Venturemed Group, Inc. | 2020-09-11 |
| XO Score Percutaneous Transluminal Angioplasty Scoring Catheter (K193495) | Transit Scientific | 2020-05-29 |
| Serranator PTA Serration Balloon Catheter (K193181) | Cagent Vascular, LLC | 2020-04-15 |
| Scoreflex PTA Scoring Balloon Catheter (K182713) | Orbusneich Medical Trading, Inc. | 2019-06-11 |
| ULTRASCORE Focused Force PTA Balloon (K172571) | C. R. Bard | 2017-09-22 |
| UltraScore Focused Force PTA Balloon (K163420) | Bard Peripheral Vascular, Inc. | 2017-06-14 |
| Serranator Alto PTA Serration Balloon Catheter (K163380) | Cagent Vascular, LLC | 2017-02-13 |
| FLEX SCORING CATHETER (K152789) | Venturemed Group | 2016-05-25 |
| 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter (K151253) | Boston Scientific Limited | 2015-06-10 |
| AngioSculpt PTA Scoring Baloon Catheters (K150634) | Spectranetrics | 2015-04-08 |
| ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER (K141322) | Cook Incorporated | 2015-03-27 |
| AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating (K142983) | Angioscore, Inc. | 2015-03-04 |
| ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING (K133998) | Angioscore, Inc. | 2014-04-18 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER (K122685) | Angioscore, Inc. | 2013-01-11 |
| SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE (K113103) | Rex Medical | 2012-05-22 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER (K112182) | Angioscore, Inc. | 2011-08-26 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER (K110767) | Angioscore, Inc. | 2011-04-15 |
| VASCUTRAK PTA DILATATION CATHETER (K103459) | C.R. Bard, Inc. | 2010-12-13 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY (K101735) | Angioscore, Inc. | 2010-07-14 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY (K100303) | Angioscore, Inc. | 2010-03-22 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 (K091966) | Angioscore, Inc. | 2009-07-30 |
| VASCUTRAK 2, MODELS: V14 AND V18 (K082343) | Ymed, Inc. | 2008-09-11 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER (K082059) | Angioscore, Inc. | 2008-08-11 |
| MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER (K081220) | Angioscore, Inc. | 2008-05-28 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039 (K080151) | Angioscore, Inc. | 2008-04-25 |
| VASCUTRAK II PTA DILATATION CATHETER (K073025) | Thermopeutix, Inc. Dba Ymed, Inc. | 2007-11-09 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER (K072225) | Angioscore, Inc. | 2007-10-12 |
| 2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS (K070951) | Boston Scientific | 2007-06-04 |
| VASCUTRAK PTA DILATION CATHETER (K063657) | Ymed, Inc. | 2006-12-12 |
| SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM (K062387) | Boston Scientific | 2006-10-05 |
| ANGIOSCULPT SCORING BALLOON CATHETER (K050629) | Angioscore, Inc. | 2005-09-02 |
| PERIPHERAL CUTTING BALLOON (K051254) | Boston Scientific Ivt | 2005-06-22 |
| 2 CM PERIPHERAL CUTTING BALOON (K041993) | Boston Scientific Ivt | 2004-08-16 |
| PERIPHERAL CUTTING BALLOON (K040155) | Boston Scientific Corp | 2004-07-01 |