External Cerebrospinal Fluid (csf) Diversion

Device Code: 3780

Product Code(s): PCB

Definition: Cerebrospinal Fluid (CSF) Diversion Intended To Alter Spinal Cord Perfusion.

Device Classification Information

• Device Type ID: 3780
• Device Name: External Cerebrospinal Fluid (csf) Diversion
• Physical State: CSF Drainage System.
• Technical Method: Diverts CSF In Order To Alter Spinal Cord Perfusion Pressures.
• Target Area: Central Nervous System (CNS) Subarachnoid And Ventricular Space.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Neurological And Physical Medicine Devices (DNPMD); Neurointerventional Devices Branch (NIDB)
• Submission Type: 510(k)
• CFR Regulation Number: 882.5560 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: PCB
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

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.

Total Product Life Cycle

• Device Type ID: 3780
• Device: External Cerebrospinal Fluid (csf) Diversion
• Product Code: PCB
• FDA Device Classification: Class 2 Medical Device
• CFR Regulation Number: 882.5560 [🔎]

Premarket Reviews
Manufacturer	Decision
MEDTRONIC INC.
	GRANTED	1
MEDTRONIC, INC.
	GRANTED	1

TPLC Last Update: 2019-04-02 20:36:40