The following data is part of a premarket notification filed by Toray Industries (america), Inc. with the FDA for Toray Vascular Prosthesis.
| Device ID | K884083 |
| 510k Number | K884083 |
| Device Name: | TORAY VASCULAR PROSTHESIS |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | TORAY INDUSTRIES (AMERICA), INC. 9223 ILONA LN. Houston, TX 77025 |
| Contact | Lisa S Jones |
| Correspondent | Lisa S Jones TORAY INDUSTRIES (AMERICA), INC. 9223 ILONA LN. Houston, TX 77025 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-27 |
| Decision Date | 1989-01-12 |