The following data is part of a premarket notification filed by Intervascular, Inc. with the FDA for Ochsner 50 Bifurcation.
| Device ID | K903964 |
| 510k Number | K903964 |
| Device Name: | OCHSNER 50 BIFURCATION |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | INTERVASCULAR, INC. 16331 BAY VISTA DR. Clearwater, FL 33760 -3130 |
| Contact | Michael Dayton |
| Correspondent | Michael Dayton INTERVASCULAR, INC. 16331 BAY VISTA DR. Clearwater, FL 33760 -3130 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-28 |
| Decision Date | 1990-12-03 |