TORAY SUPERSELECTIVE GUIDEWIRES, ADDITIONAL TYPES

Wire, Guide, Catheter

TORAY INDUSTRIES (AMERICA), INC.

The following data is part of a premarket notification filed by Toray Industries (america), Inc. with the FDA for Toray Superselective Guidewires, Additional Types.

Pre-market Notification Details

Device IDK874542
510k NumberK874542
Device Name:TORAY SUPERSELECTIVE GUIDEWIRES, ADDITIONAL TYPES
ClassificationWire, Guide, Catheter
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 CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-03
Decision Date1988-03-07

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