NRY · Catheter, Thrombus Retriever · Chrysalis Intelligence

Device class

Class II

Regulation 870.1250

Total clearances

2020-02-27 → 2026-08-13

Last 12 months

Unique sponsors

Definition

What is Catheter, Thrombus Retriever

The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.1250

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
Penumbra, Inc.	8	1	2026-06-10
Alembic, LLC	7	1	2026-08-12
Imperative Care, Inc.	6	1	2025-10-30
Perfuze, Ltd.	6	3	2026-08-12
Cerenovus, Inc.	5	1	2026-08-13
Rapid Medical , Ltd.	5	2	2026-03-12
Neuravi Limited	4	1	2025-09-25
Route 92 Medical, Inc.	3	0	2025-05-19
Balt USA, LLC	2	0	2025-06-03
Scientia Vascular, Inc.	2	1	2026-07-16
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	2	0	2024-10-29
Wallaby Medical	2	0	2024-10-01
Vesalio, Inc.	1	1	2025-11-10
Suzhou Zenith Vascular SciTech Limited	1	1	2026-05-20
QApel Medical, Inc.	1	1	2026-05-07
Phenox, Ltd.	1	1	2026-01-15
Codman & Shurtleff, Inc.	1	0	2020-07-20
Q'Apel Medical, Inc.	1	0	2023-08-25
MicroVention, Inc.	1	0	2022-03-31

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
61645	CPT	—	High	Thrombus retrieval, percutaneous, by mechanical thrombectomy device; ischemic stroke treatment

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-13	K262398	CERENOVUS, Inc.	CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set
2026-08-12	K262399	Perfuze, Ltd.	Millipede System
2026-08-12	K262391	Alembic, LLC	APRO 35 Swift Catheter and Alembic Aspiration Tubing
2026-07-16	K260002	Scientia Vascular, Inc.	Socrates Aspiration System (Socrates 70 Aspiration Catheter)
2026-06-10	K250690	Penumbra, Inc.	Penumbra System (Thunderbolt Aspiration Tubing)
2026-05-20	K252707	Suzhou Zenith Vascular SciTech Limited	Zenith Aspiration Catheter; Disposable Aspiration Tubing Set
2026-05-07	K254276	QApel Medical, Inc.	Lynx Aspiration Catheter System
2026-03-16	K253590	Perfuze, Ltd.	Millipede System
2026-03-12	K253062	Rapid Medical , Ltd.	Tigertriever 25 Revascularization Device
2026-01-15	K251357	Phenox, Ltd.	Esperance pHLO Aspiration System
2025-11-10	K251006	Vesalio, Inc.	NeVasc Aspiration System
2025-10-30	K252046	Imperative Care, Inc.	Zoom System (Zoom 4S Catheter)
2025-10-06	K251603	Rapid Medical , Ltd.	Tigertriever 17 Ultra Revascularization Device
2025-09-25	K251789	Neuravi Limited	EMBOTRAP III Revascularization Device
2025-08-29	K252392	Perfuze, Ltd.	Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set
2025-08-22	K251828	Cerenovus, Inc.	CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set
2025-06-03	K243948	Balt USA, LLC	Raptor Aspiration Catheter; Balt Aspiration Tubing Set
2025-05-28	K243047	Imperative Care, Inc.	Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing
2025-05-19	K243601	Route 92 Medical, Inc.	Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
2025-04-30	K251015	Alembic, LLC	APRO 45 Catheter and Alembic Aspiration Tubing
2025-04-28	K250958	Alembic, LLC	APRO 55 Swift Catheter and Alembic Aspiration Tubing
2025-02-26	K250012	Perfuze, Ltd.	Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
2025-02-24	K243287	Alembic, LLC	APRO 70 Swift Catheter and Alembic Aspiration Tubing
2025-02-13	K242104	Penumbra, Inc.	Penumbra System (Reperfusion Catheter RED 72)
2025-01-14	K242672	Imperative Care, Inc.	Zoom System