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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name wire, guide, catheter
510(k) Number K924558
Device Name ARROW BLOOD CONTAINMENT DEVICE
Original Applicant
ARROW INTL., INC.
p.o. box 12888
3000 bernville rd
reading,  PA  19612
Original Contact thomas d nickel
Regulation Number870.1330
Classification Product Code
DQX  
Subsequent Product Code
FOZ  
Date Received09/09/1992
Decision Date 08/19/1993
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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