GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM


Device Classification Name

electrode, pacing and cardioversion, temporary, epicardial

510(k) Number K024071
Device Name GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
Original Applicant
GUIDANT CORPORATION, CARDIAC SURGERY
3200 lakeside dr.
santa clara, 
CA 
95054

Original Contact debbie cogan
Regulation Number 870.3680
Classification Product Code
NHW  
Date Received 12/10/2002
Decision Date 02/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No