QJP · Product Code · Chrysalis Intelligence

Device class

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Regulation —

Total clearances

2020-02-27 → 2026-07-13

Last 12 months

Unique sponsors

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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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.	7	0	2024-10-02
Balt USA, LLC	6	3	2026-07-13
Asahi Intecc Co., Ltd.	6	1	2026-05-11
Perfuze, Ltd.	5	1	2026-07-09
Imperative Care, Inc.	5	0	2024-06-06
Penumbra, Inc.	5	0	2024-12-11
Cerenovus, Inc.	4	0	2024-10-16
Maduro Medical, Inc.	3	1	2026-04-09
Shanghai Heartcare Medical Technology Co., Ltd.	3	0	2023-12-22
Q'Apel Medical, Inc.	3	0	2024-11-20
Scientia Vascular, Inc.	2	0	2024-12-04
Neuravi Limited	2	0	2024-04-18
Marblehead Medical	2	0	2021-01-28
Piraeus Medical	2	0	2025-05-23
Rist Neurovascular, Inc.	2	0	2020-09-28
Mivi Neuroscience, Inc.	2	0	2023-09-19
Unity Medical, Inc.	2	1	2025-10-24
MicroVention, Inc., d/b/a Terumo Neuro	2	2	2026-06-30
Bend IT Technologies, Ltd.	2	1	2025-12-03
Crossroads Neurovascular, Inc.	2	1	2026-04-15
MicroVention, Inc.	2	0	2024-05-16
Sonorous NV, Inc.	1	1	2026-04-21
Anoxia Medical, Inc.	1	0	2023-12-01
Suzhou Zenith Vascular SciTech Limited	1	1	2026-05-22

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
2026-07-13	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
2025-05-23	K251044	Piraeus Medical	93 NeuFlex Catheter
2025-05-09	K242392	Crossroads Neurovascular, Inc.	PATH BGC
2025-03-21	K242289	Stryker Neurovascular	Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter
2025-02-18	K243593	Stryker Neurovascular	AXS Lift Intracranial Base Catheter

QJP · Unclassified

Clearance volume by quarter

Top sponsors in this product code

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

Most recent 510(k) clearances