LiteSaber Wire Torque Assist Device

Wire, Guide, Catheter

Vesatek, LLC

The following data is part of a premarket notification filed by Vesatek, Llc with the FDA for Litesaber Wire Torque Assist Device.

Pre-market Notification Details

Device IDK200120
510k NumberK200120
Device Name:LiteSaber Wire Torque Assist Device
ClassificationWire, Guide, Catheter
Applicant Vesatek, LLC 17171 Daimler Street Irvine,  CA  92614
ContactDavid Look
CorrespondentPaul Gasser
Vesatek, LLC 17171 Daimler Street Irvine,  CA  92614
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-21
Decision Date2020-05-07

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