The following data is part of a premarket notification filed by Intervascular, Inc. with the FDA for Intervascularochsner 50 And Ochsner 500 Vascular.
| Device ID | K854845 |
| 510k Number | K854845 |
| Device Name: | INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | INTERVASCULAR, INC. 4906-A CREEKSIDE DR. Clearwater, FL 33520 |
| Contact | George Goicoechea |
| Correspondent | George Goicoechea INTERVASCULAR, INC. 4906-A CREEKSIDE DR. Clearwater, FL 33520 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-04 |
| Decision Date | 1986-08-18 |