TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE

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 Guidewire,superselec Y-k Type.

Pre-market Notification Details

Device IDK861115
510k NumberK861115
Device Name:TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE
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 Received1986-03-25
Decision Date1986-07-11

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