KRD · Device, Vascular, For Promoting Embolization

Device class

Class II

Regulation 870.3300

Total clearances

2020-02-04 → 2026-07-31

Last 12 months

Unique sponsors

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.3300

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
Boston Scientific Corporation	5	2	2026-07-24
Okami Medical	3	1	2026-04-10
Medtronic, Inc.	2	2	2026-06-24
Suzhou Haowei Medical Technology Co., Ltd.	2	1	2026-07-31
Instylla, Inc.	2	1	2025-12-15
MicroVention, Inc.	2	0	2022-12-21
Nuvascular, Inc.	2	1	2026-06-12
Abk Biomedical, Inc.	2	0	2024-02-13
Varian Medical Systems, Inc.	2	0	2025-01-17
Penumbra, Inc.	1	0	2025-03-14
Obsidio, Inc.	1	0	2022-07-01
Merit Medical Systems, Inc.	1	0	2024-05-02
Balt USA, LLC	1	0	2025-05-30
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	1	0	2021-02-09
Embolic Acceleration, LLC	1	0	2020-02-14
Canyon Medical, Inc.	1	0	2025-09-23
Embolization, Inc.	1	0	2025-05-15
Artio Medical, Inc.	1	0	2022-03-21
C.R. Bard, Inc.	1	0	2020-02-04
Hangzhou Yangshun Medical Technology Co.,Ltd	1	0	2024-05-30
Bait USA, LLC	1	0	2022-04-08
Artventive Medical Group, Inc.	1	0	2022-03-01
Suzhou Hengrui Hongyuan Medical Co., Ltd.	1	0	2021-10-01
Biosphere Medical, S.A.	1	0	2025-05-16
Merit Medical System, Inc.	1	0	2021-12-15

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
36200	CPT	—	Medium	Introduction of catheter into aorta
36245	CPT	—	Medium	Selective catheterization of each intracranial branch of the carotid or vertebral arteries
37204	CPT	—	Medium	Transcatheter occlusion or embolization; arterial; nonhepatocellular carcinoma

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-31	K252812	Suzhou Haowei Medical Technology Co., Ltd.	UniPearls® Embolic Microspheres
2026-07-24	K261488	Boston Scientific Corporation	OBSIDIO Conformable Embolic
2026-06-24	K261866	Medtronic, Inc.	Concerto Versa Detachable Coil
2026-06-12	K260635	Nuvascular, Inc.	HARBOR Occlusion Device
2026-04-10	K260508	Okami Medical, Inc.	LOBO Vascular Occlusion System
2026-01-14	K253511	Medtronic, Inc.	Concerto Versa Detachable Coil
2025-12-15	K253677	Instylla, Inc.	Tembo Embolic System
2025-10-30	K253376	Boston Scientific Corporation	OBSIDIO Conformable Embolic (M0013972101010)
2025-09-23	K250209	Canyon Medical, Inc.	Polyvinyl Alcohol Embolic Microspheres
2025-07-09	K250133	Nuvascular, Inc.	HARBOR Occlusion Device
2025-05-30	K251383	Balt USA, LLC	Prestige Coil System (Prestige Packing Line Extension)
2025-05-16	K250971	Biosphere Medical, S.A.	Embosphere Microspheres
2025-05-15	K250276	Embolization, Inc.	Nitinol Enhanced Device (NED)
2025-03-14	K250079	Penumbra, Inc.	Ruby XL System
2025-01-17	K242608	Varian Medical Systems, Inc.	Embozene Color-Advanced Microspheres
2024-12-16	K240873	Instylla, Inc.	TEMBO Embolic System
2024-10-16	K242794	Varian Medical Systems, Inc.	ONCOZENE Microspheres
2024-10-03	K242507	Boston Scientific	OBSIDIO Conformable Embolic
2024-05-30	K232934	Hangzhou Yangshun Medical Technology Co.,Ltd	Sunsphere
2024-05-02	K240261	Merit Medical Systems, Inc.	Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)
2024-02-13	K234123	Abk Biomedical, Inc.	Easi-Vue® embolic microspheres System
2023-11-14	K231554	Suzhou Haowei Medical Technology Co., Ltd.	UniPearls® Embolic Microspheres
2023-06-27	K230706	Boston Scientific Corporation	EMBOLD Soft Detachable Coil System
2022-12-21	K223050	MicroVention, Inc.	AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)
2022-09-07	K220567	Abk Biomedical, Inc.	Easi-Vue embolic microspheres System