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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 K003371
Device Name PUMP TUBING WITH X-COATING
Applicant
TERUMO CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Applicant Contact GARRY A COURTNEY
Correspondent
TERUMO CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Correspondent Contact GARRY A COURTNEY
Regulation Number870.4210
Classification Product Code
DWF  
Date Received10/30/2000
Decision Date 12/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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