Symetrex LTHD Catheter, Symetrex LTHD Catheter With Sideholes

Catheter, Hemodialysis, Implanted

Medical Components Inc. (Dba Medcomp)

The following data is part of a premarket notification filed by Medical Components Inc. (dba Medcomp) with the FDA for Symetrex Lthd Catheter, Symetrex Lthd Catheter With Sideholes.

Pre-market Notification Details

Device IDK202176
510k NumberK202176
Device Name:Symetrex LTHD Catheter, Symetrex LTHD Catheter With Sideholes
ClassificationCatheter, Hemodialysis, Implanted
Applicant Medical Components Inc. (Dba Medcomp) 1499 Delp Drive Harleysville,  PA  19438
ContactCourtney Nix
CorrespondentCourtney Nix
Medical Components Inc. (Dba Medcomp) 1499 Delp Drive Harleysville,  PA  19438
Product CodeMSD  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-04
Decision Date2020-09-03

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