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

GUDID 05391530910507

The pRESET Delta LITE Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing acute ischemic stroke due to large vessel occlusion with thrombus. The device is designed for use in large vessels of the neurovasculature such as the internal carotid artery (ICA) and middle cerebral artery (MCA).

PHENOX LIMITED

Thrombectomy wire-net

• Primary Device ID: 05391530910507
• NIH Device Record Key: 9749deeb-53c7-4789-99b4-85ec23ae1ef2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pRESET® Delta LITE Thrombectomy Device (4mm x 20mm)
• Version Model Number: PRE2-LT-4-20
• Company DUNS: 985621869
• Company Name: PHENOX LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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 Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391530910507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242676

FDA Product Code

• NRY: Catheter, Thrombus Retriever

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: 2025-03-11
• Device Publish Date: 2025-03-03

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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): 2025-03-11The pRESET Delta LITE Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing acute ischemic stroke due to large vessel occlusion with thrombus. The device is designed for use in large vessels of the neurovasculature such as the internal carotid artery (ICA) and middle cerebral artery (MCA).
• 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
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