Product Classification

• Device: catheter, ventricular
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: HCA
• Premarket Review: Neurological and Physical Medicine Devices (OHT5); Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
• Submission Type: 510(k)
• Regulation Number: 882.4100
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 5-108 ISO 80369-6 First Edition 2016-03-15
  Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.
• 17-4 ASTM F647-94 (Reapproved 2014)
  Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
• 17-12 ISO 7197 Third edition 2006-06-01
  Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)]

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