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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 K161026
Device Name NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm)
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 Joseph DePaolo
Regulation Number876.5540
Classification Product Code
MSD  
Date Received04/12/2016
Decision Date 08/09/2016
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
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