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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 K845045
Device Name VENOUS RETURN CATHETER SS-1
Applicant
DLP, INC.
620 WATSON S.W., P.O. BOX 409
GRAND RAPIDS,  MI  49501
Applicant Contact RONALD A WILLIAMS
Correspondent
DLP, INC.
620 WATSON S.W., P.O. BOX 409
GRAND RAPIDS,  MI  49501
Correspondent Contact RONALD A WILLIAMS
Regulation Number870.4210
Classification Product Code
DWF  
Date Received12/28/1984
Decision Date 04/03/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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