MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER


Device Classification Name

shunt, central nervous system and components

510(k) Number K110560
Device Name MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER
Applicant
MEDTRONIC NEUROSURGERY
125 cremona dr.
goleta, 
CA 
93117

Applicant Contact jeffrey henderson
Correspondent
MEDTRONIC NEUROSURGERY
125 cremona dr.
goleta, 
CA 
93117

Correspodent Contact jeffrey henderson
Regulation Number 882.5550
Classification Product Code
JXG  
Date Received 02/28/2011
Decision Date 11/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes