Esperance pHLO Aspiration System

GUDID 05391530910231

As part of the Esperance pHLO Aspiration System, the Esperance pHLO Aspiration Catheter with a compatible aspiration pump and the Esperance Aspiration Tubing Set is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

PHENOX LIMITED

Thrombectomy suction catheter

• Primary Device ID: 05391530910231
• NIH Device Record Key: d3b3bd80-5756-405f-bd22-ac4e5cbc5d03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Esperance pHLO Aspiration System
• Version Model Number: PHLO-AC-71-125
• 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: true
• 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

• Catheter Length: 125 Centimeter
• Catheter Length: 125 Centimeter
• Catheter Length: 125 Centimeter
• Catheter Length: 125 Centimeter
• Catheter Length: 125 Centimeter
• Catheter Length: 125 Centimeter
• Catheter Length: 125 Centimeter
• Catheter Length: 125 Centimeter
• Catheter Length: 125 Centimeter
• Catheter Length: 125 Centimeter
• Catheter Length: 125 Centimeter
• Catheter Length: 125 Centimeter
• Catheter Length: 125 Centimeter
• Catheter Length: 125 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391530910231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251357

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: 2026-02-18
• Device Publish Date: 2026-02-10

On-Brand Devices [Esperance pHLO Aspiration System]

• 05391530910248: As part of the Esperance pHLO Aspiration System, the Esperance pHLO Aspiration Catheter with a c
• 05391530910231: As part of the Esperance pHLO Aspiration System, the Esperance pHLO Aspiration Catheter with a c