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 |