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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K013182
Device Name TRIPLE LUMEN CENTRAL VENOUS CATHETER
Applicant
Cook, Inc.
925 S. Curry Pike
P.O. Box 489
Bloomington,  IN  47402
Applicant Contact LISA HOPKINS
Correspondent
Cook, Inc.
925 S. Curry Pike
P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact LISA HOPKINS
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/24/2001
Decision Date 07/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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