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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 K862153
Device Name ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE
Applicant
ARROW INTL., INC.
P.O. BOX 6306
HILL AND GEORGE AVENUES
READING,  PA  19610
Applicant Contact RONALD P CITRON
Correspondent
ARROW INTL., INC.
P.O. BOX 6306
HILL AND GEORGE AVENUES
READING,  PA  19610
Correspondent Contact RONALD P CITRON
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received06/05/1986
Decision Date 12/11/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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