pRESET® LITE Thrombectomy Device (4mm x 20mm)

GUDID 05391530910101

The pRESET® LITE Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing ischemic stroke due to acute vessel occlusion with thrombus.

PHENOX LIMITED

Thrombectomy wire-net

• Primary Device ID: 05391530910101
• NIH Device Record Key: f062c426-b460-4c88-842b-c2d3c39e036a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pRESET® LITE Thrombectomy Device (4mm x 20mm)
• Version Model Number: PRE-LT-4-20
• Company DUNS: 985621869
• Company Name: PHENOX LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	05391530910101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231539

FDA Product Code

• POL: Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-21
• Device Publish Date: 2023-11-13

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• 05391530910477 - pRESET® Delta Thrombectomy Device (4mm x 20mm): 2025-03-11 The pRESET Delta Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thrombus
• 05391530910484 - pRESET® Delta Thrombectomy Device (5mm x 40mm): 2025-03-11 The pRESET Delta Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thrombus
• 05391530910491 - pRESET® Delta LITE Thrombectomy Device (3mm x 20mm): 2025-03-11 The pRESET Delta LITE Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thr
• 05391530910507 - pRESET® Delta LITE Thrombectomy Device (4mm x 20mm): 2025-03-11 The pRESET Delta LITE Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thr
• 05391530910378 - pNOVUS 21 Microcatheter (150cm): 2024-12-10 The pNOVUS 21 Microcatheter is indicated for use with compatible accessories, such as guidewires and guide catheters, in the del