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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Hemodialysis, Implanted
510(k) Number K173805
Device Name NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)
Applicant
Marvao Medical Devices, Ltd.
Gmit Innovation In Business Centre, Dublin Rd.
Galway,  IE H91 DCH9
Applicant Contact Christopher Davey
Correspondent
Boston Biomedical Associates
100 Crowley Dr.
Suite 216
Malborough,  MA  01752
Correspondent Contact Mary P LeGraw
Regulation Number876.5540
Classification Product Code
MSD  
Date Received12/15/2017
Decision Date 02/08/2018
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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