CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2


Device Classification Name

computer, diagnostic, programmable

510(k) Number K112007
Device Name CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2
Applicant
BIOSENSE WEBSTER, INC.
3333 diamond canyon rd
diamond bar, 
CA 
91765

Applicant Contact wayne r hohman
Correspondent
BIOSENSE WEBSTER, INC.
3333 diamond canyon rd
diamond bar, 
CA 
91765

Correspodent Contact wayne r hohman
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 07/14/2011
Decision Date 10/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls