Health Line CT Midline Catheter

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

Health Line International Corporation

The following data is part of a premarket notification filed by Health Line International Corporation with the FDA for Health Line Ct Midline Catheter.

Pre-market Notification Details

Device IDK200263
510k NumberK200263
Device Name:Health Line CT Midline Catheter
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant Health Line International Corporation 5675 W 300 S Salt Lake City,  UT  84104
ContactAaron G Faulkner
CorrespondentAaron G Faulkner
Health Line International Corporation 5675 W 300 S Salt Lake City,  UT  84104
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelGeneral Hospital
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-03
Decision Date2020-03-12

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