510(k) K110560

MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER by Medtronic Neurosurgery — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2011
Date Received
February 28, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type