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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K981782
Device Name LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM
Original Applicant
ARROW INTL., INC.
1600 providence highway
walpole,  MA  02081
Original Contact bradley j enegren
Regulation Number870.1340
Classification Product Code
DYB  
Date Received05/20/1998
Decision Date 08/12/1998
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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