Cannula, Ventricular

Device Code: 3722

Product Code(s): HCD

Device Classification Information

• Device Type ID: 3722
• Device Name: Cannula, Ventricular
• Regulation Description: Ventricular Cannula.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Neurological And Physical Medicine Devices (DNPMD); Neurodiagnostic And Neurosurgical Devices Branch (NDNB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 882.4060 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: HCD
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized 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)]

Total Product Life Cycle

• Device Type ID: 3722
• Device: Cannula, Ventricular
• Product Code: HCD
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Ventricular Cannula.
• CFR Regulation Number: 882.4060 [🔎]

Device Problems
Adverse Event Without Identified Device Or Use Problem	8
Material Protrusion / Extrusion	6
Leak / Splash	1
Scratched Material	1
Crack	1
Total Device Problems	17

TPLC Last Update: 2019-04-02 20:35:19