ANTHRON CATHETERS & SETS

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

TORAY INDUSTRIES (AMERICA), INC.

The following data is part of a premarket notification filed by Toray Industries (america), Inc. with the FDA for Anthron Catheters & Sets.

Pre-market Notification Details

Device IDK861117
510k NumberK861117
Device Name:ANTHRON CATHETERS & SETS
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant TORAY INDUSTRIES (AMERICA), INC. 280 PARK AVE. New York,  NY  10017
ContactKohki Ueno
CorrespondentKohki Ueno
TORAY INDUSTRIES (AMERICA), INC. 280 PARK AVE. New York,  NY  10017
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-25
Decision Date1986-06-18

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