GuideLiner V3 Catheter

Catheter, Percutaneous

Vascular Solutions, Inc.

The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Guideliner V3 Catheter.

Pre-market Notification Details

Device IDK172090
510k NumberK172090
Device Name:GuideLiner V3 Catheter
ClassificationCatheter, Percutaneous
Applicant Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis,  MN  55369
ContactBeka Vite
CorrespondentBeka Vite
Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis,  MN  55369
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-11
Decision Date2017-10-20
Summary:summary

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