QJP · Catheter, Percutaneous, Neurovasculature

Device class

Class II

Regulation 870.1250

Total clearances

100

2020-02-27 → 2026-09-16

Last 12 months

Unique sponsors

Definition

What is Catheter, Percutaneous, Neurovasculature

To provide vascular access to the neurovasculature for interventional or diagnostic procedures

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
Stryker Neurovascular	9	2	2026-07-01
Route 92 Medical, Inc.	8	1	2026-09-16
Asahi Intecc Co., Ltd.	6	1	2026-05-11
Imperative Care, Inc.	6	1	2026-08-28
Balt USA, LLC	6	3	2026-07-13
Perfuze, Ltd.	5	1	2026-07-09
Penumbra, Inc.	5	0	2024-12-11
Cerenovus, Inc.	4	0	2024-10-16
Maduro Medical, Inc.	3	1	2026-04-09
Q'Apel Medical, Inc.	3	0	2024-11-20
Piraeus Medical	3	1	2026-09-04
Shanghai Heartcare Medical Technology Co., Ltd.	3	0	2023-12-22
MicroVention, Inc., d/b/a Terumo Neuro	2	2	2026-06-30
Unity Medical, Inc.	2	1	2025-10-24
Marblehead Medical	2	0	2021-01-28
MicroVention, Inc.	2	0	2024-05-16
Wallaby Medical	2	1	2026-08-18
Neuravi Limited	2	0	2024-04-18
Scientia Vascular, Inc.	2	0	2024-12-04
Mivi Neuroscience, Inc.	2	0	2023-09-19
Bend IT Technologies, Ltd.	2	1	2025-12-03
Crossroads Neurovascular, Inc.	2	1	2026-04-15
Rist Neurovascular, Inc.	2	0	2020-09-28
Guangzhou Easycess Medical Co.,Ltd	1	0	2022-05-31
Fuji Systems Corporation	1	0	2022-12-09

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
36005	CPT	—	High	Catheterization for diagnostic/interventional neurovasculature access is standard CPT code
36010	CPT	—	Medium	Alternative catheterization code depending on vessel location and approach

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-16	K260220	Route 92 Medical, Inc.	Route 92 Medical Full Length 046 Access System
2026-09-04	K262277	Piraeus Medical, Inc.	70 NeuGlide Catheter
2026-08-28	K261176	Imperative Care, Inc.	Zoom 4S Catheter
2026-08-18	K254071	Wallaby Medical	p17 XR Microcatheter
2026-07-13	K260199	Balt USA, LLC	SLIM Microcatheter
2026-07-09	K253901	Perfuze, Ltd.	Millipede88 Access Catheter
2026-07-01	K261889	Stryker Neurovascular	Trevo Trak 21 Microcatheter
2026-06-30	K261808	Microvention Inc. d/b/a Terumo Neuro	ISAAC Neurovascular Navigation Catheter
2026-06-09	K261549	MicroVention, Inc., d/b/a Terumo Neuro	BOBBY Balloon Guide Catheter
2026-05-22	K253359	Suzhou Zenith Vascular SciTech Limited	Zenith Distal Access Long Sheath
2026-05-11	K254178	Asahi Intecc Co., Ltd.	SAYA 86 Radial Access Guide Catheter
2026-04-21	K254046	Sonorous NV, Inc.	BosCATH Support Catheter
2026-04-16	K254223	Balt USA, LLC	Next Generation 088 Catheter
2026-04-15	K260938	Crossroads Neurovascular, Inc.	PATH BGC
2026-04-09	K253975	Maduro Medical, Inc.	Radical 6F Access Catheter
2026-02-11	K253032	Stryker Neurovascular	AXS Lift Intracranial Base Catheter
2026-01-16	K252297	Toro Neurovascular, Inc.	Toro 88 Superbore Catheter
2026-01-06	K251097	Vesalio, Inc.	V-DAC Catheter
2026-01-05	K251668	Kaneka Americas Holding, Inc.	SurfRider 13 Microcatheter
2025-12-03	K252213	Bend IT Technologies, Ltd.	Bendit17 Microcatheter
2025-10-24	K251372	Unity Medical, Inc.	VersaD Delivery Catheter
2025-10-22	K252569	Balt USA, LLC	Carrier XL Delivery Catheter
2025-09-08	K250960	Rev Neuro, LLC	DUO Microcatheter
2025-06-20	K251560	Asahi Intecc Co., Ltd.	FUBUKI XF-R Neurovascular Long Sheath
2025-06-20	K251240	Asahi Intecc Co., Ltd.	Branchor X Balloon Guide Catheter