Radifocus Glidewire

Wire, Guide, Catheter

ASHITAKA FACTORY OF TERUMO CORP.

The following data is part of a premarket notification filed by Ashitaka Factory Of Terumo Corp. with the FDA for Radifocus Glidewire.

Pre-market Notification Details

Device IDK152740
510k NumberK152740
Device Name:Radifocus Glidewire
ClassificationWire, Guide, Catheter
Applicant ASHITAKA FACTORY OF TERUMO CORP. 150 MAIMAIGI-CHO Fujinomiya Shizuoka,  JP 418-0015
ContactPhebe Varghese
CorrespondentPhebe Varghese
TERUMO MEDICAL CORPORATION 265 DAVIDSON AVENUE, SUITE 320 Somerset,  NJ  08873
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-23
Decision Date2015-11-16
Summary:summary

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