FDA Product Code
FDA Product Code POL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5600
510(k) Clearances — 18 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242676 | pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device | Phenox Limited | 2025-02-28 | Special | PDF ↗ |
| K231539 | pRESET LITE Thrombectomy Device | Phenox Limited | 2023-10-21 | Traditional | PDF ↗ |
| K223305 | Trevo NXT ProVue Retriever | Stryker Neurovascular | 2023-03-29 | Traditional | PDF ↗ |
| K222848 | pRESET Thrombectomy Device | Phenox Limited | 2023-01-20 | Traditional | PDF ↗ |
| K210502 | Trevo NXT ProVue Retriever | Stryker Neurovascular | 2021-08-27 | Traditional | PDF ↗ |
| K203358 | Solitaire X Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-03-01 | Traditional | PDF ↗ |
| K203219 | Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever | Stryker Neurovascular | 2020-12-29 | Traditional | PDF ↗ |
| K193576 | Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-11-20 | Traditional | PDF ↗ |
| K200117 | Trevo NXT ProVue Retriever | Stryker | 2020-02-07 | Special | PDF ↗ |
| K192207 | Trevo NXT ProVue Retriever | Stryker | 2019-11-22 | Traditional | PDF ↗ |
| K190779 | Trevo XP ProVue Retriever | Stryker | 2019-06-25 | Traditional | PDF ↗ |
| K181807 | Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2019-03-06 | Traditional | PDF ↗ |
| K183022 | Solitaire 4 Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2019-01-29 | Traditional | PDF ↗ |
| K181186 | Solitare Platinum Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-10-25 | Traditional | PDF ↗ |
| K181060 | Solitaire 2 and Solitaire Platinum Revascularization Device | Medtronic Neurovascular | 2018-08-24 | Traditional | PDF ↗ |
| K173352 | Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) | Concentric Medical, Inc. | 2018-02-15 | Traditional | PDF ↗ |
| K162539 | Solitaire 2 Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2016-11-10 | Traditional | PDF ↗ |
| DEN150049 | Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm | Concentric Medical, Inc. | 2016-09-02 | Direct | — |
Product code POL · Class II · Neurology. Data: openFDA.