HCG · Product Code · Chrysalis Intelligence

Sponsor	Clearances	Last 12 mo	Most recent
Balt USA, LLC	5	2	2026-01-27
Stryker Neurovascular	4	2	2025-12-11
MicroPort NeuroTech (Shanghai) Co., Ltd.	4	1	2026-05-20
Medos International SARL	2	0	2022-07-14
Stryker Neurovscular	2	1	2026-06-24
Kaneka Pharma America, LLC	1	0	2020-04-25
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	1	0	2021-07-07
Cerenovus, Inc.	1	1	2026-08-14
Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular	1	0	2023-11-07
Penumbra, Inc.	1	0	2023-10-25
Kaneka Medical America, LLC	1	0	2021-03-26

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
61645	CPT	—	High	Percutaneous placement of intravascular stents; cerebral
61710	CPT	—	High	Intracranial arteriovenous malformation; embolization

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-14	K262419	Cerenovus, Inc.	MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF
2026-06-24	K261772	Stryker Neurovscular	Target Xtra Detachable Coil
2026-05-20	K260351	MicroPort NeuroTech (Shanghai) Co., Ltd.	Numen Helia Coil Embolization System; NumenFR Detachment System
2026-01-27	K254221	Balt USA, LLC	Optima Coil System (OptiOne Coil System)
2025-12-11	K252694	Stryker Neurovascular	Target Detachable Coil
2025-10-17	K251832	Stryker Neurovascular	InZone IST Detachment System; IZDS Connecting Cable
2025-09-26	K252700	Balt USA, LLC	Optima Coil System (Optima Packing Coil System)
2024-09-30	K242154	MicroPort NeuroTech (Shanghai) Co., Ltd.	Numen Coil Embolization System; NumenFR Detachment System
2024-09-27	K242582	Balt USA, LLC	Optima Coil System (OptiBlock Line Extension)
2024-08-29	K242243	Stryker Neurovscular	Target Detachable Coils
2024-01-10	K232955	MicroPort NeuroTech (Shanghai) Co., Ltd.	Numen Coil Embolization System; NumenFR Detachment System
2023-11-07	K233420	Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular	Axium Detachable Coil; Axium Prime Detachable Coil
2023-10-25	K230284	Penumbra, Inc.	Penumbra LP Coil System
2022-12-14	K222533	Stryker Neurovascular	Target Tetra Detachable Coils
2022-12-06	K223386	Balt USA, LLC	Optima Coil System
2022-07-14	K220040	Medos International SARL	CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems
2021-11-16	K212455	Stryker Neurovascular	InZone Detachment System
2021-09-01	K203625	MicroPort NeuroTech (Shanghai) Co., Ltd.	Numen Coil Embolization System; NumenFR Detachment System
2021-07-07	K203432	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	Axium Detachable Coil; Axium Prime Detachable Coil
2021-05-28	K211344	Medos International SARL	MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems
2021-03-26	K210638	Kaneka Medical America, LLC	i-ED COIL System
2020-04-25	K192068	Kaneka Pharma America, LLC	i-ED COIL
2020-02-01	K200030	Balt USA, LLC	Optima Coil System

HCG · Unclassified

Clearance volume by quarter

Top sponsors in this product code

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

Most recent 510(k) clearances