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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 K163452
Device Name PICC Maximal Barrier Nursing Kit
Applicant
Navilyst Medical, Inc.
26 Forest Street
Marlborough,  MA  01752
Applicant Contact Robin Fuller
Correspondent
Navilyst Medical, Inc.
26 Forest Street
Marlborough,  MA  01752
Correspondent Contact Robin Fuller
Regulation Number880.5970
Classification Product Code
LJS  
Subsequent Product Code
PND  
Date Received12/09/2016
Decision Date 02/03/2017
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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