CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM


Device Classification Name

neurological stereotaxic instrument

510(k) Number K022126
Device Name CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM
Original Applicant
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
826 coal creek cir.
louisville, 
CO 
80027

Original Contact victoria g rendon
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 07/01/2002
Decision Date 01/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No