Product Classification

• Device: catheter, percutaneous, neurovasculature
• Regulation Description: Percutaneous catheter.
• Definition: To provide vascular access to the neurovasculature for interventional or diagnostic procedures
• Physical State: Percutaneous catheter for neurovasculature
• Technical Method: Uses a catheter to provide access to the neurovasculature for interventional or diagnostic procedures
• Target Area: Neurovasculature
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Neurology
• Product Code: QJP
• Premarket Review: Office of Neurological and Physical Medicine Devices (OHT5); Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
• Submission Type: 510(k)
• Regulation Number: 870.1250
• 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

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc