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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 K875353
Device Name PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT
Applicant
Dlp, Inc.
P.O.Box 409
620 Watsons SW
Grand Rapids,  MI  49501
Applicant Contact VAN HOF
Correspondent
Dlp, Inc.
P.O.Box 409
620 Watsons SW
Grand Rapids,  MI  49501
Correspondent Contact VAN HOF
Regulation Number870.4210
Classification Product Code
DWF  
Date Received12/31/1987
Decision Date 03/22/1988
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
Recalls CDRH Recalls
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