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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K862056
Device Name [CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP
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 Number870.1250
Classification Product Code
DQY  
Date Received05/30/1986
Decision Date 08/25/1986
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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