NEXUS MIDLINE CT 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 Nexus Midline Ct Catheter.

Pre-market Notification Details

Device IDK140270
510k NumberK140270
Device Name:NEXUS MIDLINE CT CATHETER
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant HEALTH LINE INTERNATIONAL CORPORATION PO BOX 2786 St. George,  UT  84771 -2786
ContactJohn E Lincoln
CorrespondentJohn E Lincoln
HEALTH LINE INTERNATIONAL CORPORATION PO BOX 2786 St. George,  UT  84771 -2786
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-03
Decision Date2014-08-20
Summary:summary

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