Product Classification

• Device: ultrasound, infusion, system
• Regulation Description: Diagnostic intravascular catheter.
• Definition: For regional infusion of contrast materials into selected vessels in the neuro-vasculature. The device may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Neurology
• Product Code: NUI
• Premarket Review: Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A); Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
• Submission Type: 510(k)
• Regulation Number: 870.1200
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 12-275 IEC 61161 Edition 3.0 2013-01
  Ultrasonics -- Power measurement -- Radiation force balances and performance requirements

Third Party Review

Not Third Party Eligible