pRESET LITE Thrombectomy Device
FDA 510(k) K231539 · Phenox Limited
510(k) numberK231539
Submission
- Device name
- pRESET LITE Thrombectomy Device
- Applicant
- Phenox Limited
Galway, IE - Received
- May 30, 2023
- Decision date
- October 21, 2023
- 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 |
| 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 |
| K193576 | Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device…POL · Traditional | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 11/20/2020SE |
| 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 |
|---|---|---|
| K251357 | Esperance pHLO Aspiration SystemNRY · Traditional | 01/15/2026SE |
| K242676 | pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy DevicePOL · Special | 02/28/2025SE |
| K242420 | pNOVUS 21 MicrocatheterDQO · Traditional | 11/12/2024SE |
| K222848 | pRESET Thrombectomy DevicePOL · Traditional | 01/20/2023SE |
| K221279 | pNOVUS 21 MicrocatheterDQO · Traditional | 11/28/2022SE |
| K191687 | pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension WireDQX · Traditional | 10/09/2019SE |
Questions and answers
When was pRESET LITE Thrombectomy Device cleared by the FDA?
pRESET LITE Thrombectomy Device (K231539) received a 510(k) decision of Substantially Equivalent on October 21, 2023, 144 days after the submission was received.
What is the product code of K231539?
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.