pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
FDA 510(k) K242676 · Phenox Limited
Submission
- Device name
- pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
- Applicant
- Phenox Limited
Galway, IE - Received
- September 6, 2024
- Decision date
- February 28, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|---|
| 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 |
| 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 |
| K242420 | pNOVUS 21 MicrocatheterDQO · Traditional | 11/12/2024SE |
| K231539 | pRESET LITE Thrombectomy DevicePOL · Traditional | 10/21/2023SE |
| 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 Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device cleared by the FDA?
pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device (K242676) received a 510(k) decision of Substantially Equivalent on February 28, 2025, 175 days after the submission was received.
What is the product code of K242676?
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.