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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K011761
Device Name MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT
Original Applicant
ARROW INTL., INC.
2400 bernville rd.
reading,  PA  19605
Original Contact thomas d nickel
Regulation Number870.1340
Classification Product Code
DYB  
Subsequent Product Code
FOZ  
Date Received06/06/2001
Decision Date 10/31/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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