The following data is part of a premarket notification filed by Toray Industries (america), Inc. with the FDA for Torayguide Guidewire.
Device ID | K042370 |
510k Number | K042370 |
Device Name: | TORAYGUIDE GUIDEWIRE |
Classification | Wire, Guide, Catheter |
Applicant | TORAY INDUSTRIES (AMERICA), INC. 540 COLLEGE ST. Bellaire, TX 77401 -5010 |
Contact | Lisa S Jones |
Correspondent | Lisa S Jones TORAY INDUSTRIES (AMERICA), INC. 540 COLLEGE ST. Bellaire, TX 77401 -5010 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-08-31 |
Decision Date | 2004-12-17 |
Summary: | summary |