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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 K151239
Device Name NMI DUAL PORT II
Applicant
Navilyst Medical, Inc.
26 Forest St.
Marlborough,  MA  01752
Applicant Contact ROBIN FULLER
Correspondent
Navilyst Medical, Inc.
26 Forest St.
Marlborough,  MA  01752
Correspondent Contact ROBIN FULLER
Regulation Number880.5965
Classification Product Code
LJT  
Date Received05/11/2015
Decision Date 06/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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