QEW · Peripheral Mechanical Thrombectomy With Aspiration

Device class

Class II

Regulation 870.5150

Total clearances

2020-03-04 → 2026-08-04

Last 12 months

Unique sponsors

Definition

What is Peripheral Mechanical Thrombectomy With Aspiration

To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.5150

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
Inari Medical, Inc.	30	1	2025-10-29
Penumbra, Inc.	17	3	2026-04-24
Devoro Medical, Inc.	5	0	2024-05-29
Surmodics,Inc.	5	0	2024-09-11
Inquis Medical	5	0	2025-06-13
Contego Medical, Inc.	4	0	2025-06-13
Argon Medical Devices, Inc.	4	1	2026-02-05
Vascular Medcure, Inc.	3	0	2020-12-22
Ichor	2	0	2024-07-18
Imperative Care, Inc.	2	1	2025-08-28
Truvic Medical, Inc.	2	0	2023-02-23
C.R. Bard, Inc.	2	0	2023-03-31
Endovascular Engineering, Inc.	2	1	2025-12-18
Avantec Vascular Corporation	1	1	2026-01-07
Medtronic, Ireland	1	0	2025-06-11
Vesalio	1	0	2021-01-15
Verge Medical, Inc.	1	1	2026-01-21
Vetex Medical, Ltd.	1	0	2020-12-22
Boston Scientific Corporation	1	0	2020-10-02
Jupiter Endovascular	1	1	2026-08-04
Intervene	1	1	2025-10-22
2mg, Inc.	1	0	2023-03-31
Expanse Medical, Inc.	1	0	2024-04-19
Akura Medical	1	1	2025-11-25
Irani Medical, Inc.	1	0	2021-02-23

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
37184	CPT	—	High	Percutaneous thrombectomy (vessel other than coronary/bypass graft) with aspiration
37185	CPT	—	High	Percutaneous thrombectomy for peripheral arterial occlusion

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-04	K261523	Jupiter Endovascular	Vertex Thrombectomy System
2026-04-24	K260599	Penumbra, Inc.	INDIGO® Aspiration System INDIGO Link
2026-02-05	K260028	Argon Medical Devices, Inc.	CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister
2026-02-05	K251949	Penumbra, Inc.	INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
2026-01-21	K253730	Verge Medical, Inc.	RoVo Mechanical Thrombectomy System
2026-01-07	K251207	Avantec Vascular Corporation	Sangria Thrombectomy System
2025-12-18	K252956	Endovascular Engineering, Inc.	Helo Thrombectomy System
2025-11-25	K251070	Akura Medical	Akura Thrombectomy System
2025-10-29	K253323	Inari Medical	Protrieve Sheath
2025-10-22	K251185	Intervene	Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)
2025-10-16	K252612	Penumbra, Inc.	INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing
2025-08-28	K252057	Imperative Care, Inc.	Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System
2025-06-13	K251485	Contego Medical, Inc.	Excipio LV Prime Thrombectomy Device
2025-06-13	K251189	Inquis Medical	Aventus Thrombectomy System
2025-06-11	K250787	Medtronic, Ireland	Liberant Thrombectomy System
2025-05-14	K250775	Imperative Care, Inc.	Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy System
2025-05-12	K250421	Inari Medical, Inc.	InThrill Thrombectomy System
2025-03-25	K250668	Inquis Medical	Aventus Thrombectomy System (IM-2100)
2025-03-13	K250088	Inari Medical, Inc.	FlowTriever2 Catheter
2025-02-26	K250202	Inquis Medical	Aventus Thrombectomy System
2024-10-15	K241894	Inari Medical, Inc.	Artix MT; Artix Thin-Walled Thrombectomy Sheath
2024-09-27	K242557	Inari Medical, Inc.	ClotTriever XL Catheter (41-102)
2024-09-25	K242075	Penumbra, Inc.	Indigo® Aspiration System Lightning Bolt Aspiration Tubing
2024-09-11	K241362	Surmodics,Inc.	Pounce XL Thrombectomy System (PTS-1011-7F135)
2024-09-03	K242319	Penumbra, Inc.	Indigo® Aspiration System Aspiration Catheter 6X