CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER


Device Classification Name

catheter, cannula and tubing, vascular, cardiopulmonary bypass

510(k) Number K023880
Device Name CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
Original Applicant
ETHICON, INC.
p.o box 151, route 22 west
somerville, 
NJ 
08876

Original Contact peter cecchini
Regulation Number 870.4210
Classification Product Code
DWF  
Date Received 11/21/2002
Decision Date 12/11/2002
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