TrapLiner Catheter

Catheter, Percutaneous

Vascular Solutions, Inc.

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

Pre-market Notification Details

Device IDK161901
510k NumberK161901
Device Name:TrapLiner 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 Received2016-07-11
Decision Date2017-02-03
Summary:summary

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