Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)
FDA 510(k) K193576 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Submission
- Device name
- Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Irvine, CA, US - Received
- December 23, 2019
- Decision date
- November 20, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- POL – Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5600
- Specialty
- Neurology
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.
Other 510(k)s with product code POL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242676 | pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy DevicePOL · Special | Phenox Limited | 02/28/2025SE |
| K231539 | pRESET LITE Thrombectomy DevicePOL · Traditional | Phenox Limited | 10/21/2023SE |
| K223305 | Trevo NXT ProVue RetrieverPOL · Traditional | Stryker Neurovascular | 03/29/2023SE |
| K222848 | pRESET Thrombectomy DevicePOL · Traditional | Phenox Limited | 01/20/2023SE |
| K210502 | Trevo NXT ProVue RetrieverPOL · Traditional | Stryker Neurovascular | 08/27/2021SE |
| K203358 | Solitaire X Revascularization DevicePOL · Traditional | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 03/01/2021SE |
| K203219 | Trevo XP ProVue Retriever and Trevo NXT ProVue RetrieverPOL · Traditional | Stryker Neurovascular | 12/29/2020SE |
| K200117 | Trevo NXT ProVue RetrieverPOL · Special | Stryker | 02/07/2020SE |
| K192207 | Trevo NXT ProVue RetrieverPOL · Traditional | Stryker | 11/22/2019SE |
| K190779 | Trevo XP ProVue RetrieverPOL · Traditional | Stryker | 06/25/2019SE |
More from Stryker
| 510(k) | Device | Decision |
|---|---|---|
| K241388 | Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…QJP · Special | 01/02/2025SE |
| K243418 | Riptide Aspiration Pump; Riptide Collection Canister with Intermediate TubingJCX · Special | 12/02/2024SE |
| K243080 | Riptide Aspiration SystemNRY · Special | 10/29/2024SE |
| K211990 | Rist 071 Radial Access Guide CatheterDQY · Special | 07/27/2021SE |
| K203432 | Axium Detachable Coil; Axium Prime Detachable CoilHCG · Traditional | 07/07/2021SE |
| K203358 | Solitaire X Revascularization DevicePOL · Traditional | 03/01/2021SE |
| K202850 | Concerto Versa, Detachable CoilKRD · Traditional | 02/09/2021SE |
| K202318 | Marathon Flow Directed Micro CatheterKRA · Special | 09/14/2020SE |
| K201690 | Mirage Hydrophilic Guidewire; X-pedion Hydrophilic GuidewireDQX · Special | 07/21/2020SE |
| K201689 | Riptide Aspiration SystemNRY · Special | 07/21/2020SE |
Questions and answers
When was Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) cleared by the FDA?
Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) (K193576) received a 510(k) decision of Substantially Equivalent on November 20, 2020, 333 days after the submission was received.
What is the product code of K193576?
The FDA product code is POL – Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment, a Class II (moderate risk) device regulated under 21 CFR 882.5600.