LIT · Catheter, Angioplasty, Peripheral, Transluminal

Device class

Class II

Regulation 870.1250

Total clearances

2020-01-15 → 2026-09-21

Last 12 months

Unique sponsors

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
Biotronik, Inc.	4	0	2025-04-04
Cordis Corporation	3	0	2021-04-23
Kossel Medtech (Suzhou) Co., Ltd.	3	1	2026-09-16
Natec Medical , Ltd.	3	1	2025-12-18
OrbusNeich Medical (Shenzhen) Co., Ltd.	3	0	2024-06-11
Summa Therapeutics, LLC	2	0	2024-07-16
Brosmed Medical Co., Ltd.	2	0	2025-02-27
Creagh Medical, Ltd.	2	0	2023-03-22
Boston Scientific Corporation	2	0	2024-07-10
Abbott Vascular	1	0	2022-05-05
Zylox Medtech Co., Ltd.	1	1	2026-09-21
Contego Medical, Inc.	1	0	2022-06-09
C.R. Bard, Inc.	1	0	2023-01-20
Creagh Medical Ltd. Dba Surmodics, Inc.	1	0	2024-11-15
Infinity Angioplasty Balloon Company, LLC	1	0	2020-05-20
Nexstep Medical	1	0	2020-01-15
Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,	1	0	2021-06-16
Medtronic, Inc.	1	0	2021-12-15
WAVE Medical AG	1	1	2026-05-20
Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC)	1	0	2020-11-18
Qualimed USA, LLC	1	0	2021-08-03
Dk Medical Technology Co., Ltd.	1	0	2023-04-05
Cordis US Corp	1	0	2022-08-22
ABBOTT MEDICAL	1	1	2026-02-13
Silk Road Medical, Inc.	1	0	2022-09-02

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
37220	CPT	—	High	CPT code for percutaneous angioplasty of peripheral vessels with imaging guidance
37223	CPT	—	Medium	Alternative CPT for peripheral transluminal angioplasty with stent

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-21	K260416	Zylox Medtech Co., Ltd.	ZYLOX Hippo PTA Balloon Dilatation Catheter
2026-09-16	K254212	Kossel Medtech (Suzhou) Co., Ltd.	NC PTA Balloon Dilatation Catheter
2026-05-20	K260304	WAVE Medical AG	WAVE PTA Balloon Catheter
2026-02-13	K252512	ABBOTT MEDICAL	Armada 14 NC PTA Catheter
2025-12-18	K251915	Natec Medical , Ltd.	Amethyst HP PTA OTW 0.035 Catheter
2025-04-04	K250706	Biotronik, Inc.	Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
2025-02-27	K243704	Brosmed Medical Co., Ltd.	Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter
2024-12-18	K241040	Natec Medical , Ltd.	Amethyst HP PTA OTW 0.035 Catheter
2024-11-15	K242419	Creagh Medical Ltd. Dba Surmodics, Inc.	018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
2024-07-16	K241740	Summa Therapeutics	Finesse Injectable PTA Balloon Dilatation Catheter
2024-07-11	K241711	Biotronik, Inc.	Oscar Peripheral Multifunctional Catheter system
2024-07-10	K241683	Boston Scientific Corporation	Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031406020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031408020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031410020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031412020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031415020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H749390314
2024-06-11	K241025	OrbusNeich Medical (Shenzhen) Co., Ltd.	JADE PLUS PTA Balloon Dilatation Catheter
2023-12-20	K231402	Kossel Medtech (Suzhou) Co., Ltd.	HP PTA Balloon Dilatation Catheter
2023-05-26	K230263	Summa Therapeutics, LLC	Finesse Injectable PTA Balloon Dilatation Catheter
2023-04-05	K214009	Dk Medical Technology Co., Ltd.	D·Kaptain PTA High Pressure Balloon Dilatation Catheter
2023-03-22	K230191	Creagh Medical, Ltd.	Arise UHP Dilatation Catheter
2023-02-16	K222065	Biotronik, Inc.	Passeo-35 Xeo Peripheral Dilatation Catheter
2023-01-20	K223177	C.R. Bard, Inc.	Highlander 014 PTA Balloon Dilatation Catheter
2022-12-14	K221245	Kossel Medtech (Suzhou) Co., Ltd.	PTA Balloon Dilatation Catheter
2022-09-02	K221414	Silk Road Medical, Inc.	ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter
2022-08-22	K221832	Cordis US Corp	SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter
2022-07-19	K212215	Brosmed Medical Co., Ltd.	Tiche PTA Balloon Dilatation Catheter
2022-07-06	K214038	Biotronik, Inc.	Oscar Peripheral Multifunctional Catheter system
2022-06-29	K220410	Natec Medical , Ltd.	Ebony HP PTA OTW 0.035 Catheter