VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02


Device Classification Name

catheter, electrode recording, or probe, electrode recording

510(k) Number K081258
Device Name VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02
Applicant
BIOSENSE WEBSTER, INC.
3333 diamond canyon rd.
diamond bar, 
CA 
91765

Applicant Contact natalie bennington
Correspondent
BIOSENSE WEBSTER, INC.
3333 diamond canyon rd.
diamond bar, 
CA 
91765

Correspodent Contact natalie bennington
Regulation Number 870.1220
Classification Product Code
DRF  
Date Received 05/02/2008
Decision Date 01/06/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No