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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name port & catheter, implanted, subcutaneous, intravascular
510(k) Number K003006
Device Name TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION
Original Applicant
ARROW INTL., INC.
2400 bernville rd.
reading,  PA  19605
Original Contact thomas d nickel
Regulation Number880.5965
Classification Product Code
LJT  
Date Received09/26/2000
Decision Date 10/27/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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