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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 K030231
Device Name CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON
Applicant
Sorin Group Italia S.R.L.
86, Via Statale 12 Nord
Mirandola,  IT 41037
Applicant Contact Luigi Vecchi
Correspondent
Vitalcor, Inc.
100 E. Chestnut Ave.
Westmont,  IL  60559
Correspondent Contact Gregory Huck
Regulation Number870.4210
Classification Product Code
DWF  
Date Received01/22/2003
Decision Date 04/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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