RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER

Catheter, Intravascular, Diagnostic

TERUMO MEDICAL CORP.

The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Radifocus Optitorque Angiographic Catheter.

Pre-market Notification Details

Device IDK082736
510k NumberK082736
Device Name:RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
ClassificationCatheter, Intravascular, Diagnostic
Applicant TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton,  MD  21921
ContactMark Unterreiner
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-09-18
Decision Date2008-09-24
Summary:summary

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