The following data is part of a premarket notification filed by Toray Industries (america), Inc. with the FDA for Toray Anthron Aorta Bypass Tubes.
Device ID | K872762 |
510k Number | K872762 |
Device Name: | TORAY ANTHRON AORTA BYPASS TUBES |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | TORAY INDUSTRIES (AMERICA), INC. 280 PARK AVE. New York, NY 10017 |
Contact | Kohki Ueno |
Correspondent | Kohki Ueno TORAY INDUSTRIES (AMERICA), INC. 280 PARK AVE. New York, NY 10017 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-13 |
Decision Date | 1987-09-24 |