CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)


Device Classification Name

computer, diagnostic, programmable

510(k) Number K103746
Device Name CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)
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 12/23/2010
Decision Date 01/21/2011
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