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.
Device ID | K861115 |
510k Number | K861115 |
Device Name: | TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE |
Classification | Wire, Guide, Catheter |
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 | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-25 |
Decision Date | 1986-07-11 |