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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 K173667
Device Name 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes
Applicant
Medical Components, Inc. (dba MedComp)
1499 Delp Dr.
Harleysville,  PA  19438
Applicant Contact Courtney Nix
Correspondent
Medical Components, Inc. (dba MedComp)
1499 Delp Dr.
Harleysville,  PA  19438
Correspondent Contact Courtney Nix
Regulation Number876.5540
Classification Product Code
MSD  
Date Received11/30/2017
Decision Date 05/17/2018
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
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