510(k) DEN150049
- Device
- Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm
- Applicant
- Concentric Medical, Inc.
- 510(k) number
- DEN150049
- Product code
- POL
- Decision
- Unknown (DENG)
- Decision date
- 2016-09-02
- Date received
- 2015-10-26
- Regulation
- 882.5600
- Classification name
- Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- JIM LEATHLEY
- Address
- 301 E. Evelyn Ave. Mountain View CA US 94041 94041
FDA Registration Numbers#
- 1721676
- 3006451981
- 2029214
- 3016540856
- 3031288142
- 3015550451
- 3012931345
- 3009380063
- 3012497308
- 3007007790
- 3013656790
- 3008853977
- 2011171
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code POL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242676 | pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device | Phenox Limited | 2025-02-28 |
| K231539 | pRESET LITE Thrombectomy Device | Phenox Limited | 2023-10-21 |
| K223305 | Trevo NXT ProVue Retriever | Stryker Neurovascular | 2023-03-29 |
| K222848 | pRESET Thrombectomy Device | Phenox Limited | 2023-01-20 |
| K210502 | Trevo NXT ProVue Retriever | Stryker Neurovascular | 2021-08-27 |
| K203358 | Solitaire X Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-03-01 |
| K203219 | Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever | Stryker Neurovascular | 2020-12-29 |
| K193576 | Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-11-20 |
| K200117 | Trevo NXT ProVue Retriever | Stryker | 2020-02-07 |
| K192207 | Trevo NXT ProVue Retriever | Stryker | 2019-11-22 |
| K190779 | Trevo XP ProVue Retriever | Stryker | 2019-06-25 |
| K181807 | Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2019-03-06 |
| K183022 | Solitaire 4 Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2019-01-29 |
| K181186 | Solitare Platinum Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-10-25 |
| K181060 | Solitaire 2 and Solitaire Platinum Revascularization Device | Medtronic Neurovascular | 2018-08-24 |