The following data is part of a premarket notification filed by Intervascular, Inc. with the FDA for Low Porosity (lp) Vascular Prosthesis.
| Device ID | K912911 |
| 510k Number | K912911 |
| Device Name: | LOW POROSITY (LP) VASCULAR PROSTHESIS |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | INTERVASCULAR, INC. 16331 BAY VISTA DR. Clearwater, FL 33760 -3130 |
| Contact | Michael P Dayton |
| Correspondent | Michael P 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 | 1991-07-02 |
| Decision Date | 1991-09-23 |