Atlas FDA

POL

18 FDA 510(k) clearances · Product code

123 daysmedian time to decision
312 days90th percentile
18clearances measured

FDA profile

Official device name
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5600
Medical specialty
Neurology
FDA definition
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.
Adverse events (MAUDE)
2021: 21 · 2023: 23
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device (K242676)Phenox Limited2025-02-28
pRESET LITE Thrombectomy Device (K231539)Phenox Limited2023-10-21
Trevo NXT ProVue Retriever (K223305)Stryker Neurovascular2023-03-29
pRESET Thrombectomy Device (K222848)Phenox Limited2023-01-20
Trevo NXT ProVue Retriever (K210502)Stryker Neurovascular2021-08-27
Solitaire X Revascularization Device (K203358)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2021-03-01
Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever (K203219)Stryker Neurovascular2020-12-29
Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) (K193576)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2020-11-20
Trevo NXT ProVue Retriever (K200117)Stryker2020-02-07
Trevo NXT ProVue Retriever (K192207)Stryker2019-11-22
Trevo XP ProVue Retriever (K190779)Stryker2019-06-25
Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) (K181807)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2019-03-06
Solitaire 4 Revascularization Device (K183022)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2019-01-29
Solitare Platinum Revascularization Device (K181186)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2018-10-25
Solitaire 2 and Solitaire Platinum Revascularization Device (K181060)Medtronic Neurovascular2018-08-24
Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) (K173352)Concentric Medical, Inc.2018-02-15
Solitaire 2 Revascularization Device (K162539)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2016-11-10
Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm (DEN150049)Concentric Medical, Inc.2016-09-02

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Every clearance here is in the API, with alerts when new ones post.