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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 K840001
Device Name ARTERIAL CANNULA STRAIGHT BEVELED TIP
Applicant
DLP, INC.
620 WATSON S.W., P.O. BOX 409
GRAND RAPIDS,  MI  49501
Applicant Contact JAMES DEVRIES
Correspondent
DLP, INC.
620 WATSON S.W., P.O. BOX 409
GRAND RAPIDS,  MI  49501
Correspondent Contact JAMES DEVRIES
Regulation Number870.4210
Classification Product Code
DWF  
Date Received01/03/1984
Decision Date 02/13/1984
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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