Product Code: PNO
FDA class 2
21 CFR 870.1250
Catheter, Percutaneous, Cutting/Scoring
Cardiovascular
The Catheter, Percutaneous, Cutting/Scoring (product code PNO) is a Class 2 cardiovascular device intended to reduce vascular stenosis by dilatation and apposition of cutting or scoring surfaces to stenotic material within the vasculature, regulated under 870.1250. It requires 510(k) clearance and falls under the cardiovascular medical specialty. The device is not an implant and is not life-sustaining.
510(k)s
45
FEI Numbers
32
Registration Numbers
32
Unique Applicants
22
Years Active
22
Basic Information
- Product Code
- PNO
- Device Class
- FDA class 2
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 45 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K260012 | UltraScore Focused Force PTA Balloon | Feb 04, 2026 | Substantially Equivalent | Bard Peripheral Vascular, Inc. |
| K243944 | Aperta NSE PTA Balloon Dilatation Catheter | Apr 22, 2025 | Substantially Equivalent | Goodman Co., Ltd. |
| K242254 | D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter | Apr 21, 2025 | Substantially Equivalent | Dk Medical Technology Co., Ltd. |
| K241478 | Tri-Wedge PTA Scoring Balloon Dilatation Catheter | Oct 22, 2024 | Substantially Equivalent | Brosmed Medical Co., Ltd. |
| K232258 | XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter | Jun 17, 2024 | Substantially Equivalent | Transit Scientific, LLC |
| 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) | Mar 28, 2024 | Substantially Equivalent | Goodman Co., Ltd. |
| K232207 | D·Kutting PTA Scoring Balloon Dilatation Catheter | Mar 07, 2024 | Substantially Equivalent | Dk Medical Technology Co., Ltd. |
| K221986 | XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter | Oct 18, 2022 | Substantially Equivalent | Transit Scientific, LLC |
| K220704 | Serranator PTA Serration Balloon Catheter | May 04, 2022 | Substantially Equivalent | Cagent Vascular, LLC |
| K213728 | Serranator PTA Serration Balloon Catheter | Dec 15, 2021 | Substantially Equivalent | Cagent Vascular, LLC |
| K203437 | Serranator PTA Serration Balloon Catheter | Dec 22, 2020 | Substantially Equivalent | Cagent Vascular, LLC |
| K202187 | FLEX Vessel Prep System | Sep 11, 2020 | Substantially Equivalent | Venturemed Group, Inc. |
| K193495 | XO Score Percutaneous Transluminal Angioplasty Scoring Catheter | May 29, 2020 | Substantially Equivalent | Transit Scientific |
| K193181 | Serranator PTA Serration Balloon Catheter | Apr 15, 2020 | Substantially Equivalent | Cagent Vascular, LLC |
| K182713 | Scoreflex PTA Scoring Balloon Catheter | Jun 11, 2019 | Substantially Equivalent | Orbusneich Medical Trading, Inc. |
| K172571 | ULTRASCORE Focused Force PTA Balloon | Sep 22, 2017 | Substantially Equivalent | C. R. Bard |
| K163420 | UltraScore Focused Force PTA Balloon | Jun 14, 2017 | Substantially Equivalent | Bard Peripheral Vascular, Inc. |
| K163380 | Serranator Alto PTA Serration Balloon Catheter | Feb 13, 2017 | Substantially Equivalent | Cagent Vascular, LLC |
| K152789 | FLEX SCORING CATHETER | May 25, 2016 | Substantially Equivalent | Venturemed Group |
| K151253 | 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter | Jun 10, 2015 | Substantially Equivalent | Boston Scientific Limited |
| K150634 | AngioSculpt PTA Scoring Baloon Catheters | Apr 08, 2015 | Substantially Equivalent | Spectranetrics |
| K141322 | ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER | Mar 27, 2015 | Substantially Equivalent | Cook Incorporated |
| K142983 | AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating | Mar 04, 2015 | Substantially Equivalent | Angioscore, Inc. |
| K133998 | ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING | Apr 18, 2014 | Substantially Equivalent | Angioscore, Inc. |
| K122685 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | Jan 11, 2013 | Substantially Equivalent | Angioscore, Inc. |
| K113103 | SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE | May 22, 2012 | Substantially Equivalent | Rex Medical |
| K112182 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | Aug 26, 2011 | Substantially Equivalent | Angioscore, Inc. |
| K110767 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | Apr 15, 2011 | Substantially Equivalent | Angioscore, Inc. |
| K103459 | VASCUTRAK PTA DILATATION CATHETER | Dec 13, 2010 | Substantially Equivalent | C.R. Bard, Inc. |
| K101735 | ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY | Jul 14, 2010 | Substantially Equivalent | Angioscore, Inc. |
| K100303 | ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY | Mar 22, 2010 | Substantially Equivalent | Angioscore, Inc. |
| K091966 | ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 | Jul 30, 2009 | Substantially Equivalent | Angioscore, Inc. |
| K082343 | VASCUTRAK 2, MODELS: V14 AND V18 | Sep 11, 2008 | Substantially Equivalent | Ymed, Inc. |
| K082059 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | Aug 11, 2008 | Substantially Equivalent | Angioscore, Inc. |
| K081220 | MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER | May 28, 2008 | Substantially Equivalent | Angioscore, Inc. |
| K080151 | ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039 | Apr 25, 2008 | Substantially Equivalent | Angioscore, Inc. |
| K073025 | VASCUTRAK II PTA DILATATION CATHETER | Nov 09, 2007 | Substantially Equivalent | Thermopeutix, Inc. Dba Ymed, Inc. |
| K072225 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | Oct 12, 2007 | Substantially Equivalent | Angioscore, Inc. |
| K070951 | 2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS | Jun 04, 2007 | Substantially Equivalent | Boston Scientific |
| K063657 | VASCUTRAK PTA DILATION CATHETER | Dec 12, 2006 | Substantially Equivalent | Ymed, Inc. |
| K062387 | SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM | Oct 05, 2006 | Substantially Equivalent | Boston Scientific |
| K050629 | ANGIOSCULPT SCORING BALLOON CATHETER | Sep 02, 2005 | Substantially Equivalent | Angioscore, Inc. |
| K051254 | PERIPHERAL CUTTING BALLOON | Jun 22, 2005 | Substantially Equivalent | Boston Scientific Ivt |
| K041993 | 2 CM PERIPHERAL CUTTING BALOON | Aug 16, 2004 | Substantially Equivalent | Boston Scientific Ivt |
| K040155 | PERIPHERAL CUTTING BALLOON | Jul 01, 2004 | Substantially Equivalent | Boston Scientific Corp |
FEI Numbers
This FDA classification entry is associated with 32 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 32 registration numbers. Click on an entry to view related FDA registrations.