RADIFOCUS GUIDE WIRE M

Catheter, Urological

TERUMO MEDICAL CORP.

The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Radifocus Guide Wire M.

Pre-market Notification Details

Device IDK923607
510k NumberK923607
Device Name:RADIFOCUS GUIDE WIRE M
ClassificationCatheter, Urological
Applicant TERUMO MEDICAL CORP. P.O. BOX 605 Elkton,  MD  21912
ContactSandi Hartka
CorrespondentSandi Hartka
TERUMO MEDICAL CORP. P.O. BOX 605 Elkton,  MD  21912
Product CodeKOD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-16
Decision Date1992-10-02

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