R350 Guidewire

Wire, Guide, Catheter

VASCULAR SOLUTIONS, INC.

The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for R350 Guidewire.

Pre-market Notification Details

Device IDK151234
510k NumberK151234
Device Name:R350 Guidewire
ClassificationWire, Guide, Catheter
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 CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-08
Decision Date2015-11-18
Summary:summary

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