CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02


Device Classification Name

catheter, electrode recording, or probe, electrode recording

510(k) Number K080425
Device Name CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02
Applicant
BIOSENSE WEBSTER, INC.
3333 diamond canyon rd.
diamond bar, 
CA 
91765

Applicant Contact balaka das
Correspondent
BIOSENSE WEBSTER, INC.
3333 diamond canyon rd.
diamond bar, 
CA 
91765

Correspodent Contact balaka das
Regulation Number 870.1220
Classification Product Code
DRF  
Date Received 02/15/2008
Decision Date 04/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No