PDU · Catheter For Crossing Total Occlusions

Device class

Class II

Regulation 870.1250

Total clearances

2020-01-17 → 2025-09-22

Last 12 months

Unique sponsors

Definition

What is Catheter For Crossing Total Occlusions

To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.

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
Avinger, Inc.	3	0	2023-04-25
Ra Medical Systems,Inc	2	0	2022-06-29
LimFlow, Inc.	2	0	2025-05-31
Baylis Medical Technologies, Inc.	2	1	2025-09-11
Soundbite Medical Solutions, Inc.	2	0	2023-08-28
AngioSafe, Inc.	1	1	2025-09-22
Soundbite Medical Solution, Inc.	1	0	2020-01-17
C.R. Bard, Inc.	1	0	2021-08-12
Tractus Vascular, LLC	1	0	2023-01-19
Upstream Peripheral Technologies, Ltd.	1	0	2022-03-01

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
36245	CPT	—	High	Selective catheterization of vascular territory; standard code for peripheral artery catheter placement crossing occlusions
36246	CPT	—	Medium	Selective catheterization; alternative peripheral vascular access code

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2025-09-22	K252315	AngioSafe, Inc.	Santreva-ATK Endovascular Revasculariztion Catheter
2025-09-11	K251158	Baylis Medical Technologies, Inc.	PowerWire® 14 Radiofrequency Guidewire Kit
2025-05-31	K251376	LimFlow, Inc.	LimFlow ARC
2024-02-28	K232562	Baylis Medical Technologies, Inc.	PowerWire Radiofrequency Guidewire Kit
2023-08-28	K230159	Soundbite Medical Solutions, Inc.	SoundBite® Crossing System XS Peripheral
2023-04-25	K230594	Avinger, Inc.	Tigereye ST CTO-Crossing Catheter
2023-01-19	K221163	Tractus Vascular, LLC	Tunnel Crossing Catheter
2022-08-31	K221541	LimFlow, Inc.	LimFlow ARC
2022-06-29	K220544	Ra Medical Systems,Inc	DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)
2022-03-01	K211802	Upstream Peripheral Technologies, Ltd.	GoBack Crossing Catheter
2022-01-06	K212468	Avinger, Inc.	Tigereye CTO-Crossing Catheter
2021-08-12	K203363	C.R. Bard, Inc.	Crosser iQ CTO Recanalization System
2021-07-27	K210664	Ra Medical Systems,Inc	DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
2021-04-20	K210839	Soundbite Medical Solutions, Inc.	SoundBite Crossing System - Peripheral (14P)
2020-09-10	K201330	Avinger, Inc.	Tigereye CTO-Crossing Catheter
2020-01-17	K192211	Soundbite Medical Solution, Inc.	SoundBite Console, SoundBite Active Wire 18