Wattson Temporary Pacing Guidewire

Wire, Guide, Catheter

Vascular Solutions

The following data is part of a premarket notification filed by Vascular Solutions with the FDA for Wattson Temporary Pacing Guidewire.

Pre-market Notification Details

Device IDK192454
510k NumberK192454
Device Name:Wattson Temporary Pacing Guidewire
ClassificationWire, Guide, Catheter
Applicant Vascular Solutions 6464 Sycamore Court North Minneapolis,  MN  55369
ContactNancy Frame
CorrespondentNancy Frame
Vascular Solutions 6464 Sycamore Court North Minneapolis,  MN  55369
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-09
Decision Date2020-01-15

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.