RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE

Wire, Guide, Catheter

Terumo Medical Corporation

The following data is part of a premarket notification filed by Terumo Medical Corporation with the FDA for Radifocus Glidewire Advantage, Radifocus Glidewire Advantage.

Pre-market Notification Details

Device IDK122590
510k NumberK122590
Device Name:RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE
ClassificationWire, Guide, Catheter
Applicant Terumo Medical Corporation 265 DAVIDSON AVE, STE 320 Somerset,  NJ  08873
ContactStacy A Kluesner, Ms, Rac
CorrespondentStacy A Kluesner, Ms, Rac
Terumo Medical Corporation 265 DAVIDSON AVE, STE 320 Somerset,  NJ  08873
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-24
Decision Date2013-03-01
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.