MOF · Product Code · Chrysalis Intelligence

Device class

—

Regulation —

Total clearances

2020-04-16 → 2026-08-14

Last 12 months

Unique sponsors

Classification details

Medical specialty

—

Review panel

—

Regulation number

—

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
Scientia Vascular, Inc.	6	2	2026-08-06
Arbor Endovascular, LLC	5	4	2026-08-14
Asahi Intecc Co., Ltd.	2	1	2026-02-02
MicroVention, Inc.	2	0	2020-07-02
Rapid-Medical , Ltd.	2	0	2024-07-11
Imperative Care, Inc.	1	0	2025-08-26
Suzhou Zenith Vascular SciTech Limited	1	1	2026-04-16
Artiria Medical SA	1	0	2023-04-24
Rapid Medical Ltd.	1	1	2026-07-17
Terumo Medical Products (Hangzhou) Co., Ltd.	1	0	2022-06-29
Stryker Neurovascular	1	0	2020-09-25
Shanghai Achieva Medical Suzhou Co., Ltd.	1	1	2026-03-16
Enlight Medical Technologies (Shenzhen) Co., Ltd.	1	0	2024-11-18

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, arterial; external carotid artery (neurovasculature guidewire use)
36246	CPT	—	High	Selective catheterization, arterial; vertebral artery (neurovasculature guidewire use)
36247	CPT	—	Medium	Selective catheterization, arterial; intracranial branch or branch distal to the circle of Willis

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-14	K262424	Arbor Endovascular, LLC	Willow 12 Guidewire
2026-08-06	K260223	Scientia Vascular, Inc.	Aristotle Mini Guidewire
2026-07-17	K254006	Rapid Medical Ltd.	Drivewire 35 Guidewire
2026-04-29	K253579	Scientia Vascular, Inc.	Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire
2026-04-16	K252317	Suzhou Zenith Vascular SciTech Limited	Zenith Micro Guidewire
2026-03-19	K260537	Arbor Endovascular, LLC	Willow 24 Guidewire
2026-03-16	K252122	Shanghai Achieva Medical Suzhou Co., Ltd.	DCwire Micro-guidewire
2026-02-13	K260130	Arbor Endovascular, LLC	Willow 18 Guidewire
2026-02-02	K252011	Asahi Intecc Co., Ltd.	CHIKAI Nexus petit
2025-11-26	K253168	Arbor Endovascular, LLC	0.014 Willow Guidewire
2025-08-26	K244061	Imperative Care, Inc.	X-Wire Guidewire
2025-07-17	K243756	Arbor Endovascular, LLC	0.014 Willow Guidewire
2025-04-21	K243383	Asahi Intecc Co., Ltd.	CHIKAI Nexus 014
2025-04-01	K243938	Scientia Vascular, Inc.	Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire
2024-11-18	K240871	Enlight Medical Technologies (Shenzhen) Co., Ltd.	Synxess Neurovascular Guidewire
2024-07-11	K233791	Rapid-Medical , Ltd.	Drivewire 24 Guidewire
2023-08-01	K231954	Scientia Vascular, Inc.	Aristotle 18 Guidewire; Aristotle 24 Guidewire
2023-04-24	K222690	Artiria Medical SA	SmartGUIDE deflectable hydrophilic guidewire
2023-03-10	K220398	Scientia Vascular, LLC	Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire
2023-01-26	K222437	Scientia Vascular, Inc.	Aristotle Colossus Guidewire
2022-06-29	K220934	Terumo Medical Products (Hangzhou) Co., Ltd.	RADIFOCUS Torque Device
2020-12-14	K200374	Rapid-Medical , Ltd.	Columbus Guidewire
2020-09-25	K202522	Stryker Neurovascular	Synchro SELECT Guidewire
2020-07-02	K201487	MicroVention, Inc.	Traxcess 7 Mini Guidewire
2020-04-16	K200547	MicroVention, Inc.	Traxcess 14 SELECT Guidewire

MOF · Unclassified

Clearance volume by quarter

Top sponsors in this product code

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

Most recent 510(k) clearances