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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K023880
Device Name CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
Applicant
Ethicon, Inc.
P.O Box 151, Route 22 W.
Somerville,  NJ  08876
Applicant Contact PETER CECCHINI
Correspondent
Ethicon, Inc.
P.O Box 151, Route 22 W.
Somerville,  NJ  08876
Correspondent Contact PETER CECCHINI
Regulation Number870.4210
Classification Product Code
DWF  
Date Received11/21/2002
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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