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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter,intravascular,therapeutic,long-term greater than 30 days
510(K) Number K113277
Model CDC-34052-HPK1A
Device Name ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS
Applicant
ARROW INTERNATIONAL, INC.
2400 bernville rd.
reading,  PA  19605
Contact tracy maddock
Regulation Number880.5970
Classification Product Code
LJS  
Date Received11/07/2011
Decision Date 06/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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