Panels › Cardiovascular › Product code PNO · Class 2
Catheter, Percutaneous, Cutting/Scoring
Regulation 870.1250
3510(k)s in 12 months (47 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in PNO
| Company | 510(k)s | Recalls |
|---|---|---|
| Angioscore, Inc. | 13 | 0 |
| Cagent Vascular, LLC | 5 | 0 |
| Boston Scientific | 4 | 0 |
| Cook Incorporated | 1 | 3 |
| Transit Scientific | 3 | 0 |
| Bard Peripheral Vascular, Inc. | 2 | 0 |
| Boston Scientific Ivt | 2 | 0 |
| C. R. Bard | 2 | 0 |
| Dk Medical Technology Co., Ltd. | 2 | 0 |
| Goodman Co., Ltd. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 22, 2026 | K260686 | Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter Zylox Medtech Co., Ltd., CN | PNO |
| Sep 16, 2026 | K261778 | JADE SCORE PTA Scoring Balloon Dilatation Catheter OrbusNeich Medical (Shenzhen) Co., Ltd., CN | PNO |
| Feb 4, 2026 | K260012 | UltraScore Focused Force PTA Balloon Bard Peripheral Vascular, Inc. | PNO |
| Apr 22, 2025 | K243944 | Aperta NSE PTA Balloon Dilatation Catheter Goodman Co., Ltd., JP | PNO |
| Apr 21, 2025 | K242254 | D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter Dk Medical Technology Co., Ltd., CN | PNO |
| Oct 22, 2024 | K241478 | Tri-Wedge PTA Scoring Balloon Dilatation Catheter Brosmed Medical Co., Ltd., CN | PNO |
| Jun 17, 2024 | K232258 | XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter Transit Scientific, LLC | PNO |
| Mar 28, 2024 | K232013 | Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW1 Goodman Co., Ltd., JP | PNO |
| Mar 7, 2024 | K232207 | D·Kutting PTA Scoring Balloon Dilatation Catheter Dk Medical Technology Co., Ltd., CN | PNO |
| Oct 18, 2022 | K221986 | XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter Transit Scientific, LLC | PNO |
| May 4, 2022 | K220704 | Serranator PTA Serration Balloon Catheter Cagent Vascular, LLC | PNO |
| Dec 15, 2021 | K213728 | Serranator PTA Serration Balloon Catheter Cagent Vascular, LLC | PNO |
| Dec 22, 2020 | K203437 | Serranator PTA Serration Balloon Catheter Cagent Vascular, LLC | PNO |
| Sep 11, 2020 | K202187 | FLEX Vessel Prep System Venturemed Group, Inc. | PNO |
| May 29, 2020 | K193495 | XO Score Percutaneous Transluminal Angioplasty Scoring Catheter Transit Scientific | PNO |
| Apr 15, 2020 | K193181 | Serranator PTA Serration Balloon Catheter Cagent Vascular, LLC | PNO |
| Jun 11, 2019 | K182713 | Scoreflex PTA Scoring Balloon Catheter Orbusneich Medical Trading, Inc. | PNO |
| Sep 22, 2017 | K172571 | ULTRASCORE Focused Force PTA Balloon C. R. Bard | PNO |
| Jun 14, 2017 | K163420 | UltraScore Focused Force PTA Balloon Bard Peripheral Vascular, Inc. | PNO |
| Feb 13, 2017 | K163380 | Serranator Alto PTA Serration Balloon Catheter Cagent Vascular, LLC | PNO |
| May 25, 2016 | K152789 | FLEX SCORING CATHETER Venturemed Group | PNO |
| Jun 10, 2015 | K151253 | 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter Boston Scientific Limited, IE | PNO |
| Apr 8, 2015 | K150634 | AngioSculpt PTA Scoring Baloon Catheters Spectranetrics | PNO |
| Mar 27, 2015 | K141322 | ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER Cook Incorporated | PNO |
| Mar 4, 2015 | K142983 | AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating Angioscore, Inc. | PNO |
| Apr 18, 2014 | K133998 | ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING Angioscore, Inc. | PNO |
| Jan 11, 2013 | K122685 | ANGIOSCULPT PTA SCORING BALLOON CATHETER Angioscore, Inc. | PNO |
| May 22, 2012 | K113103 | SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE Rex Medical | PNO |
| Aug 26, 2011 | K112182 | ANGIOSCULPT PTA SCORING BALLOON CATHETER Angioscore, Inc. | PNO |
| Apr 15, 2011 | K110767 | ANGIOSCULPT PTA SCORING BALLOON CATHETER Angioscore, Inc. | PNO |
| Dec 13, 2010 | K103459 | VASCUTRAK PTA DILATATION CATHETER C.R. Bard, Inc. | PNO |
| Jul 14, 2010 | K101735 | ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY Angioscore, Inc. | PNO |
| Mar 22, 2010 | K100303 | ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY Angioscore, Inc. | PNO |
| Jul 30, 2009 | K091966 | ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 Angioscore, Inc. | PNO |
| Sep 11, 2008 | K082343 | VASCUTRAK 2, MODELS: V14 AND V18 Ymed, Inc. | PNO |
| Aug 11, 2008 | K082059 | ANGIOSCULPT PTA SCORING BALLOON CATHETER Angioscore, Inc. | PNO |
| May 28, 2008 | K081220 | MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER Angioscore, Inc. | PNO |
| Apr 25, 2008 | K080151 | ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039 Angioscore, Inc. | PNO |
| Nov 9, 2007 | K073025 | VASCUTRAK II PTA DILATATION CATHETER Thermopeutix, Inc. Dba Ymed, Inc. | PNO |
| Oct 12, 2007 | K072225 | ANGIOSCULPT PTA SCORING BALLOON CATHETER Angioscore, Inc. | PNO |
| Jun 4, 2007 | K070951 | 2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS Boston Scientific | PNO |
| Dec 12, 2006 | K063657 | VASCUTRAK PTA DILATION CATHETER Ymed, Inc. | PNO |
| Oct 5, 2006 | K062387 | SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM Boston Scientific | PNO |
| Sep 2, 2005 | K050629 | ANGIOSCULPT SCORING BALLOON CATHETER Angioscore, Inc. | PNO |
| Jun 22, 2005 | K051254 | PERIPHERAL CUTTING BALLOON Boston Scientific Ivt | PNO |
| Aug 16, 2004 | K041993 | 2 CM PERIPHERAL CUTTING BALOON Boston Scientific Ivt | PNO |
| Jul 1, 2004 | K040155 | PERIPHERAL CUTTING BALLOON Boston Scientific Corp | PNO |
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