# K242676: pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device

- Pathway: 510(k) (Special)
- Applicant: Phenox Limited
- Decided: Feb 28, 2025 after 175 days
- Product code: POL (Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment)
- Device class: 2
- Regulation: 21 CFR 882.5600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN150049 (2016). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222848: pRESET Thrombectomy Device, Phenox Limited (2023) Summary page 5.
- K231539: pRESET LITE Thrombectomy Device, Phenox Limited (2023) Summary page 5.

## Indications for use
1.The pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received thrombolytic therapy. Endovascular therapy with the device should be started within 6 hours of symptom onset. 2.The pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for thrombolytic therapy or who fail thrombolytic therapy are candidates for treatment.

Source page: https://510kreport.com/device/K242676
Methodology: https://510kreport.com/methodology