Chrysalis Intelligence · Product Codes · POL

POL · Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

Neurology · 9 clearances · 4 unique sponsors

Device class
Class II
Regulation 882.5600
Total clearances
9
2020-02-07 → 2025-02-28
Last 12 months
0
Unique sponsors
4
Definition

What is Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.
Medical specialty
Neurology
Review panel
NE
Regulation number
882.5600
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Stryker Neurovascular 3 0 2023-03-29
Phenox Limited 3 0 2025-02-28
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular 2 0 2021-03-01
Stryker 1 0 2020-02-07
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.

CodeTypeDescriptionConfidenceRationale
37184 CPT — High Percutaneous mechanical thrombectomy, vascular or nonvascular
61645 CPT — High Percutaneous mechanical thrombectomy and/or thrombolysis; intracranial arterial and venous
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-02-28 K242676 Phenox Limited pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
2023-10-21 K231539 Phenox Limited pRESET LITE Thrombectomy Device
2023-03-29 K223305 Stryker Neurovascular Trevo NXT ProVue Retriever
2023-01-20 K222848 Phenox Limited pRESET Thrombectomy Device
2021-08-27 K210502 Stryker Neurovascular Trevo NXT ProVue Retriever
2021-03-01 K203358 Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Solitaire X Revascularization Device
2020-12-29 K203219 Stryker Neurovascular Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever
2020-11-20 K193576 Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)
2020-02-07 K200117 Stryker Trevo NXT ProVue Retriever