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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Pump, Cardiopulmonary Bypass
510(k) Number K993189
Device Name CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING
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 Number870.4390
Classification Product Code
DWE  
Date Received09/23/1999
Decision Date 03/01/2000
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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