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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 K100635
Model S-44041-02, S-45041-002, S-455041-002, MC-44052-003, MC-45052-003, MC-45552-003
Device Name ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504
Original Applicant
ARROW INTL., INC.
2400 bernville rd.
reading,  PA  19605
Original Contact tracy maddock
Regulation Number880.5970
Classification Product Code
LJS  
Date Received03/05/2010
Decision Date 08/27/2010
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 Yes
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