FINECROSS MG CORONARY MICRO-GUIDE CATHETER

Catheter, Continuous Flush

TERUMO MEDICAL CORP.

The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Finecross Mg Coronary Micro-guide Catheter.

Pre-market Notification Details

Device IDK082519
510k NumberK082519
Device Name:FINECROSS MG CORONARY MICRO-GUIDE CATHETER
ClassificationCatheter, Continuous Flush
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 CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-09-02
Decision Date2008-09-26
Summary:summary

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