pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242676 FDA 510(k)
- FDA Product Code
- POL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5600 FDA 510(k)
- Regulation Number
- 882.5600 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are neurovascular mechanical thrombectomy devices for acute ischemic stroke treatment. They 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.
These devices are supplied sterile and intended for single-use. They are used in neurovascular settings and have received FDA 510(k) clearance under K242676, with device class 2 and product code POL. The devices are regulated under regulation number 882.5600 and are manufactured by Phenox Limited in Galway, Ireland.
Frequently asked questions
What is the pRESET Delta Thrombectomy Device used for?
The pRESET Delta Thrombectomy Device and pRESET Delta LITE are neurovascular mechanical thrombectomy devices indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing acute ischemic stroke within 8 hours of symptom onset.
How is the pRESET Delta Thrombectomy Device supplied and is it reusable?
The pRESET Delta Thrombectomy Device and pRESET Delta LITE are supplied sterile and intended for single-use only; they are not designed for reuse, reprocessing, or resterilization due to their mechanical design and material composition.
What regulatory clearance does the pRESET Delta Thrombectomy Device have?
The pRESET Delta Thrombectomy Device and pRESET Delta LITE have received FDA 510(k) clearance under K242676, are classified as class II devices with product code POL, and are regulated under regulation number 882.5600 for neurovascular mechanical thrombectomy devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy ..., pRESET Thrombectomy Device | phenox, PDF pRESET Thrombectomy Device - phenox, pRESET® Delta LITE Thrombectomy Device (3mm x 20mm)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242676 | Class II | Active |
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Manufacturer
- Manufacturer
- Phenox Limited
Sources (1)
- FDA 510(k) K242676 24 fields · synced Oct 1, 2026