Langston Dual Lumen Catheter

Catheter, Intravascular, Diagnostic

Vascular Solutions LLC

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

Pre-market Notification Details

Device IDK221470
510k NumberK221470
Device Name:Langston Dual Lumen Catheter
ClassificationCatheter, Intravascular, Diagnostic
Applicant Vascular Solutions LLC 6464 Sycamore Court North Minneapolis,  MN  55369
ContactBecky Astrup
CorrespondentBecky Astrup
Vascular Solutions LLC 6464 Sycamore Court North Minneapolis,  MN  55369
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-20
Decision Date2022-06-17

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