TORAYGUIDE GUIDEWIRE

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 Torayguide Guidewire.

Pre-market Notification Details

Device IDK042370
510k NumberK042370
Device Name:TORAYGUIDE GUIDEWIRE
ClassificationWire, Guide, Catheter
Applicant TORAY INDUSTRIES (AMERICA), INC. 540 COLLEGE ST. Bellaire,  TX  77401 -5010
ContactLisa S Jones
CorrespondentLisa S Jones
TORAY INDUSTRIES (AMERICA), INC. 540 COLLEGE ST. Bellaire,  TX  77401 -5010
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-08-31
Decision Date2004-12-17
Summary:summary

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