Langston Dual Lumen Catheter

Catheter, Intravascular, Diagnostic

Vascular Solutions, Inc.

The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Langston Dual Lumen Catheter.

Pre-market Notification Details

Device IDK170544
510k NumberK170544
Device Name:Langston Dual Lumen Catheter
ClassificationCatheter, Intravascular, Diagnostic
Applicant Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis,  MN  55369
ContactJake Schultz
CorrespondentJake Schultz
Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis,  MN  55369
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-24
Decision Date2017-11-17
Summary:summary

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