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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
Applicant
ARROW INTL., INC.
2400 BERNVILLE RD.
READING,  PA  19605
Applicant Contact THOMAS D NICKEL
Correspondent
ARROW INTL., INC.
2400 BERNVILLE RD.
READING,  PA  19605
Correspondent 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 Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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