FDA Product Code
FDA Product Code PNO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1250
510(k) Clearances — 46 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261778 | JADE SCORE PTA Scoring Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2026-09-16 | Traditional | PDF ↗ |
| K260012 | UltraScore Focused Force PTA Balloon | Bard Peripheral Vascular, Inc. | 2026-02-04 | Special | PDF ↗ |
| K243944 | Aperta NSE PTA Balloon Dilatation Catheter | Goodman Co., Ltd. | 2025-04-22 | Traditional | PDF ↗ |
| K242254 | D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | 2025-04-21 | Traditional | PDF ↗ |
| K241478 | Tri-Wedge PTA Scoring Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2024-10-22 | Traditional | PDF ↗ |
| K232258 | XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter | Transit Scientific, LLC | 2024-06-17 | Traditional | PDF ↗ |
| K232013 | 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) | Goodman Co., Ltd. | 2024-03-28 | Traditional | PDF ↗ |
| K232207 | D·Kutting PTA Scoring Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | 2024-03-07 | Traditional | PDF ↗ |
| K221986 | XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter | Transit Scientific, LLC | 2022-10-18 | Special | PDF ↗ |
| K220704 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2022-05-04 | Traditional | PDF ↗ |
| K213728 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2021-12-15 | Special | PDF ↗ |
| K203437 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2020-12-22 | Special | PDF ↗ |
| K202187 | FLEX Vessel Prep System | Venturemed Group, Inc. | 2020-09-11 | Traditional | PDF ↗ |
| K193495 | XO Score Percutaneous Transluminal Angioplasty Scoring Catheter | Transit Scientific | 2020-05-29 | Traditional | PDF ↗ |
| K193181 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2020-04-15 | Traditional | PDF ↗ |
| K182713 | Scoreflex PTA Scoring Balloon Catheter | Orbusneich Medical Trading, Inc. | 2019-06-11 | Traditional | PDF ↗ |
| K172571 | ULTRASCORE Focused Force PTA Balloon | C. R. Bard | 2017-09-22 | Special | PDF ↗ |
| K163420 | UltraScore Focused Force PTA Balloon | Bard Peripheral Vascular, Inc. | 2017-06-14 | Traditional | PDF ↗ |
| K163380 | Serranator Alto PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2017-02-13 | Traditional | PDF ↗ |
| K152789 | FLEX SCORING CATHETER | Venturemed Group | 2016-05-25 | Traditional | PDF ↗ |
| K151253 | 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter | Boston Scientific Limited | 2015-06-10 | Special | PDF ↗ |
| K150634 | AngioSculpt PTA Scoring Baloon Catheters | Spectranetrics | 2015-04-08 | Special | PDF ↗ |
| K141322 | ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER | Cook Incorporated | 2015-03-27 | Traditional | PDF ↗ |
| K142983 | AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating | Angioscore, Inc. | 2015-03-04 | Special | PDF ↗ |
| K133998 | ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING | Angioscore, Inc. | 2014-04-18 | Traditional | PDF ↗ |
| K122685 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | Angioscore, Inc. | 2013-01-11 | Traditional | PDF ↗ |
| K113103 | SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE | Rex Medical | 2012-05-22 | Traditional | PDF ↗ |
| K112182 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | Angioscore, Inc. | 2011-08-26 | Special | PDF ↗ |
| K110767 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | Angioscore, Inc. | 2011-04-15 | Special | PDF ↗ |
| K103459 | VASCUTRAK PTA DILATATION CATHETER | C.R. Bard, Inc. | 2010-12-13 | Traditional | PDF ↗ |
| K101735 | ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY | Angioscore, Inc. | 2010-07-14 | Special | PDF ↗ |
| K100303 | ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY | Angioscore, Inc. | 2010-03-22 | Traditional | PDF ↗ |
| K091966 | ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 | Angioscore, Inc. | 2009-07-30 | Special | PDF ↗ |
| K082343 | VASCUTRAK 2, MODELS: V14 AND V18 | Ymed, Inc. | 2008-09-11 | Special | PDF ↗ |
| K082059 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | Angioscore, Inc. | 2008-08-11 | Special | PDF ↗ |
| K081220 | MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER | Angioscore, Inc. | 2008-05-28 | Special | PDF ↗ |
| K080151 | ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039 | Angioscore, Inc. | 2008-04-25 | Traditional | PDF ↗ |
| K073025 | VASCUTRAK II PTA DILATATION CATHETER | Thermopeutix, Inc. Dba Ymed, Inc. | 2007-11-09 | Special | PDF ↗ |
| K072225 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | Angioscore, Inc. | 2007-10-12 | Special | PDF ↗ |
| K070951 | 2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS | Boston Scientific | 2007-06-04 | Traditional | PDF ↗ |
| K063657 | VASCUTRAK PTA DILATION CATHETER | Ymed, Inc. | 2006-12-12 | Traditional | PDF ↗ |
| K062387 | SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM | Boston Scientific | 2006-10-05 | Special | PDF ↗ |
| K050629 | ANGIOSCULPT SCORING BALLOON CATHETER | Angioscore, Inc. | 2005-09-02 | Traditional | PDF ↗ |
| K051254 | PERIPHERAL CUTTING BALLOON | Boston Scientific Ivt | 2005-06-22 | Traditional | PDF ↗ |
| K041993 | 2 CM PERIPHERAL CUTTING BALOON | Boston Scientific Ivt | 2004-08-16 | Special | PDF ↗ |
| K040155 | PERIPHERAL CUTTING BALLOON | Boston Scientific Corp | 2004-07-01 | Traditional | PDF ↗ |
Product code PNO · Class II · Cardiovascular. Data: openFDA.