TORAY ANTHRON AORTA BYPASS TUBES

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

TORAY INDUSTRIES (AMERICA), INC.

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

Pre-market Notification Details

Device IDK872762
510k NumberK872762
Device Name:TORAY ANTHRON AORTA BYPASS TUBES
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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 CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-13
Decision Date1987-09-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.