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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 K132811
Device Name SARNS SOFT-FLOW EXTENDED AORTIC CANNULA
Applicant
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd.
Ann Arbor,  MI  48103
Applicant Contact GARRY A COURTNEY
Correspondent
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd.
Ann Arbor,  MI  48103
Correspondent Contact GARRY A COURTNEY
Regulation Number870.4210
Classification Product Code
DWF  
Date Received09/09/2013
Decision Date 02/27/2014
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
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