The following data is part of a premarket notification filed by Impra, Inc. with the FDA for Vascular Graft Prost. Of Expanded Ptfe.
| Device ID | K791810 |
| 510k Number | K791810 |
| Device Name: | VASCULAR GRAFT PROST. OF EXPANDED PTFE |
| Classification | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter |
| Applicant | IMPRA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DYF |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-09-14 |
| Decision Date | 1979-10-09 |