Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Regulation 882.5600
0510(k)s in 12 months (18 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in POL
| Company | 510(k)s | Recalls |
|---|---|---|
| Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 6 | 0 |
| Stryker Neurovascular | 3 | 3 |
| Phenox Limited | 3 | 0 |
| Stryker | 3 | 0 |
| Concentric Medical, Inc. | 2 | 0 |
| Medtronic Neurovascular | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 28, 2025 | K242676 | pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device Phenox Limited, IE | POL |
| Oct 21, 2023 | K231539 | pRESET LITE Thrombectomy Device Phenox Limited, IE | POL |
| Mar 29, 2023 | K223305 | Trevo NXT ProVue Retriever Stryker Neurovascular | POL |
| Jan 20, 2023 | K222848 | pRESET Thrombectomy Device Phenox Limited, IE | POL |
| Aug 27, 2021 | K210502 | Trevo NXT ProVue Retriever Stryker Neurovascular | POL |
| Mar 1, 2021 | K203358 | Solitaire X Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | POL |
| Dec 29, 2020 | K203219 | Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever Stryker Neurovascular | POL |
| Nov 20, 2020 | K193576 | Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | POL |
| Feb 7, 2020 | K200117 | Trevo NXT ProVue Retriever Stryker | POL |
| Nov 22, 2019 | K192207 | Trevo NXT ProVue Retriever Stryker | POL |
| Jun 25, 2019 | K190779 | Trevo XP ProVue Retriever Stryker | POL |
| Mar 6, 2019 | K181807 | Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | POL |
| Jan 29, 2019 | K183022 | Solitaire 4 Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | POL |
| Oct 25, 2018 | K181186 | Solitare Platinum Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | POL |
| Aug 24, 2018 | K181060 | Solitaire 2 and Solitaire Platinum Revascularization Device Medtronic Neurovascular | POL |
| Feb 15, 2018 | K173352 | Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) Concentric Medical, Inc. | POL |
| Nov 10, 2016 | K162539 | Solitaire 2 Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | POL |
| Sep 2, 2016 | DEN150049 | Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Ret Concentric Medical, Inc. | POL |
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