ACCUCATH MIDLINE CATHETER SYSTEM

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

VASCULAR PATHWAYS, INC.

The following data is part of a premarket notification filed by Vascular Pathways, Inc. with the FDA for Accucath Midline Catheter System.

Pre-market Notification Details

Device IDK142136
510k NumberK142136
Device Name:ACCUCATH MIDLINE CATHETER SYSTEM
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant VASCULAR PATHWAYS, INC. 1847 Trade Center Way Naples,  FL  34109
ContactScott Pease
CorrespondentScott Pease
VASCULAR PATHWAYS, INC. 1847 Trade Center Way Naples,  FL  34109
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-04
Decision Date2015-01-08
Summary:summary

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