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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 K152190
Device Name Thoratec CentriMag Drainage (Venous) Cannula Kit
Applicant
Thoratec Corporation
6035 Stoneridge Dr.
Pleasnaton,  CA  94588
Applicant Contact Lori DonDiego
Correspondent
Thoratec Corporation
6035 Stoneridge Dr.
Pleasnaton,  CA  94588
Correspondent Contact Lori DonDiego
Regulation Number870.4210
Classification Product Code
DWF  
Date Received08/05/2015
Decision Date 09/18/2015
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
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