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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 K010034
Device Name DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
Applicant
Cook, Inc.
925 S. Curry Pk
Bloomington,  IN  47403
Applicant Contact LISA WEBB
Correspondent
Cook, Inc.
925 S. Curry Pk
Bloomington,  IN  47403
Correspondent Contact LISA WEBB
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received01/04/2001
Decision Date 01/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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