PNO · Catheter, Percutaneous, Cutting/Scoring

Device class

Class II

Regulation 870.1250

Total clearances

2020-04-15 → 2026-02-04

Last 12 months

Unique sponsors

Definition

What is Catheter, Percutaneous, Cutting/Scoring

To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.1250

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Cagent Vascular, LLC	4	0	2022-05-04
Transit Scientific, LLC	3	0	2024-06-17
Dk Medical Technology Co., Ltd.	2	0	2025-04-21
Goodman Co., Ltd.	2	0	2025-04-22
Brosmed Medical Co., Ltd.	1	0	2024-10-22
Bard Peripheral Vascular, Inc.	1	1	2026-02-04
Venturemed Group, Inc.	1	0	2020-09-11

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
92997	CPT	—	Medium	Percutaneous transluminal angioplasty; iliac, femoral, popliteal artery
92998	CPT	—	Medium	Percutaneous transluminal angioplasty; aorta
C1730	HCPCS	Catheter, electrophysiology, diagnostic, other than 3d mapping (19 or fewer electrodes) ✓ CMS-verified description	Medium	Catheter, transluminal angioplasty, non-laser

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-02-04	K260012	Bard Peripheral Vascular, Inc.	UltraScore Focused Force PTA Balloon
2025-04-22	K243944	Goodman Co., Ltd.	Aperta NSE PTA Balloon Dilatation Catheter
2025-04-21	K242254	Dk Medical Technology Co., Ltd.	D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter
2024-10-22	K241478	Brosmed Medical Co., Ltd.	Tri-Wedge PTA Scoring Balloon Dilatation Catheter
2024-06-17	K232258	Transit Scientific, LLC	XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter
2024-03-28	K232013	Goodman Co., Ltd.	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)
2024-03-07	K232207	Dk Medical Technology Co., Ltd.	D·Kutting PTA Scoring Balloon Dilatation Catheter
2022-10-18	K221986	Transit Scientific, LLC	XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter
2022-05-04	K220704	Cagent Vascular, LLC	Serranator PTA Serration Balloon Catheter
2021-12-15	K213728	Cagent Vascular, LLC	Serranator PTA Serration Balloon Catheter
2020-12-22	K203437	Cagent Vascular, LLC	Serranator PTA Serration Balloon Catheter
2020-09-11	K202187	Venturemed Group, Inc.	FLEX Vessel Prep System
2020-05-29	K193495	Transit Scientific	XO Score Percutaneous Transluminal Angioplasty Scoring Catheter
2020-04-15	K193181	Cagent Vascular, LLC	Serranator PTA Serration Balloon Catheter