Radifocus Optitorque Angiographic Catheter

Catheter, Intravascular, Diagnostic

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 Optitorque Angiographic Catheter.

Pre-market Notification Details

Device IDK150232
510k NumberK150232
Device Name:Radifocus Optitorque Angiographic Catheter
ClassificationCatheter, Intravascular, Diagnostic
Applicant ASHITAKA FACTORY OF TERUMO CORP. 150 MAIMAIGI-CHO Fujinomiya, Shizuoka,  JP 418-0015
ContactMonika Mcdole-russell
CorrespondentMonika Mcdole-russell
TERUMO MEDICAL CORP. 265 Davidson Ave., Suite 320 Somerset,  NJ  08873
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-02
Decision Date2015-10-19
Summary:summary

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