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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 K122545
Model CDC-44041-VPS; CDC-45041-VPS; CDC--45541-VPS
Device Name CG+ ARROW PICC POWERED BY ARROW VPS STYLET
Applicant
ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)
2400 bernville rd.
reading,  PA  19605
Contact elizabeth duncan
Regulation Number880.5970
Classification Product Code
LJS  
Subsequent Product Code
OBJ  
Date Received08/21/2012
Decision Date 09/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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