Duo-Flow Side X Side Double Lumen Catheter

Catheter, Hemodialysis, Non-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 Duo-flow Side X Side Double Lumen Catheter.

Pre-market Notification Details

Device IDK192807
510k NumberK192807
Device Name:Duo-Flow Side X Side Double Lumen Catheter
ClassificationCatheter, Hemodialysis, Non-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 CodeMPB  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-01
Decision Date2020-04-23

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