Product Classification

• Device: intracranial aneurysm flow diverter
• Definition: Treatment of wide-necked and larger or giant intracranial aneurysms.
• Physical State: metallic
• Technical Method: interventional
• Target Area: neurovasculature
• Review Panel: Neurology
• Product Code: OUT
• Premarket Review: Office of Neurological and Physical Medicine Devices (OHT5); Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 3-184 ASTM F2477-23
  Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
• 3-200 ASTM F2477-24
  Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses

Third Party Review

Not Third Party Eligible