The following data is part of a premarket notification filed by Possis Medical, Inc. with the FDA for Perma-pass Vascular Graft, 5t Graft,model 31451.
| Device ID | K984183 |
| 510k Number | K984183 |
| Device Name: | PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 |
| Classification | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter |
| Applicant | POSSIS MEDICAL, INC. 9055 EVERGREEN BLVD., N.W. Minneapolis, MN 55433 -8003 |
| Contact | Timothy J Kappers |
| Correspondent | Timothy J Kappers POSSIS MEDICAL, INC. 9055 EVERGREEN BLVD., N.W. Minneapolis, MN 55433 -8003 |
| Product Code | DYF |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-23 |
| Decision Date | 1999-02-01 |
| Summary: | summary |