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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 K002507
Device Name TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH 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 Received08/15/2000
Decision Date 03/21/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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