Product code PNO
- Device name
- Catheter, Percutaneous, Cutting/Scoring
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1250
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260012 | UltraScore™ Focused Force PTA Balloon | Bard Peripheral Vascular, Inc. | 2026-02-04 |
| K243944 | Aperta NSE PTA Balloon Dilatation Catheter | Goodman Co., Ltd. | 2025-04-22 |
| K242254 | D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | 2025-04-21 |
| K241478 | Tri-Wedge PTA Scoring Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2024-10-22 |
| K232258 | XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter | Transit Scientific, LLC | 2024-06-17 |
| 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... | Goodman Co., Ltd. | 2024-03-28 |
| K232207 | D·Kutting™ PTA Scoring Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | 2024-03-07 |
| K221986 | XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter | Transit Scientific, LLC | 2022-10-18 |
| K220704 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2022-05-04 |
| K213728 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2021-12-15 |
| K203437 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2020-12-22 |
| K202187 | FLEX Vessel Prep System | Venturemed Group, Inc. | 2020-09-11 |
| K193495 | XO Score Percutaneous Transluminal Angioplasty Scoring Catheter | Transit Scientific | 2020-05-29 |
| K193181 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2020-04-15 |
| K182713 | Scoreflex PTA Scoring Balloon Catheter | Orbusneich Medical Trading, Inc. | 2019-06-11 |
| K172571 | ULTRASCORE Focused Force PTA Balloon | C. R. Bard | 2017-09-22 |
| K163420 | UltraScore Focused Force PTA Balloon | Bard Peripheral Vascular, Inc. | 2017-06-14 |
| K163380 | Serranator Alto PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2017-02-13 |
| K152789 | FLEX SCORING CATHETER | Venturemed Group | 2016-05-25 |
| K151253 | 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter | Boston Scientific Limited | 2015-06-10 |
| K150634 | AngioSculpt PTA Scoring Baloon Catheters | Spectranetrics | 2015-04-08 |
| K141322 | ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER | Cook Incorporated | 2015-03-27 |
| K142983 | AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating | Angioscore, Inc. | 2015-03-04 |
| K133998 | ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING | Angioscore, Inc. | 2014-04-18 |
| K122685 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | Angioscore, Inc. | 2013-01-11 |
| K113103 | SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE | Rex Medical | 2012-05-22 |
| K112182 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | Angioscore, Inc. | 2011-08-26 |
| K110767 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | Angioscore, Inc. | 2011-04-15 |
| K103459 | VASCUTRAK PTA DILATATION CATHETER | C.R. Bard, Inc. | 2010-12-13 |
| K101735 | ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY | Angioscore, Inc. | 2010-07-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10827002352558 | Advance Enforcer | COOK INCORPORATED | 2016-12-09 |
| 10827002352541 | Advance Enforcer | COOK INCORPORATED | 2016-12-09 |
| 10827002352534 | Advance Enforcer | COOK INCORPORATED | 2016-12-09 |
| 10827002352527 | Advance Enforcer | COOK INCORPORATED | 2016-12-09 |
| 10827002352510 | Advance Enforcer | COOK INCORPORATED | 2016-12-09 |
| 10827002352503 | Advance Enforcer | COOK INCORPORATED | 2016-12-09 |
| 10827002352497 | Advance Enforcer | COOK INCORPORATED | 2016-12-09 |
| 10827002352480 | Advance Enforcer | COOK INCORPORATED | 2016-12-09 |
| 08714729819707 | Small Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729819769 | Small Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729819752 | Small Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729819745 | Small Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729819738 | Small Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729819721 | Small Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729819714 | Small Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729813699 | 2cm Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729819691 | Small Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729819684 | Small Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729819677 | Small Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729813804 | 2cm Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729813798 | 2cm Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729813781 | 2cm Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729813774 | 2cm Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729813767 | 2cm Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729813750 | 2cm Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729813743 | 2cm Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729813736 | 2cm Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729813729 | 2cm Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729813712 | 2cm Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729813705 | 2cm Peripheral Cutting Balloon® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |