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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
Applicant
ARROW INTL., INC.
1600 PROVIDENCE HIGHWAY
WALPOLE,  MA  02081
Applicant Contact BRADLEY J ENEGREN
Correspondent
ARROW INTL., INC.
1600 PROVIDENCE HIGHWAY
WALPOLE,  MA  02081
Correspondent Contact BRADLEY J ENEGREN
Regulation Number870.1340
Classification Product Code
DYB  
Date Received05/20/1998
Decision Date 08/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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