The following data is part of a premarket notification filed by Impra, Inc. with the FDA for Distaflo Bypass Graft.
| Device ID | K983769 |
| 510k Number | K983769 |
| Device Name: | DISTAFLO BYPASS GRAFT |
| Classification | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter |
| Applicant | IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 Tempe, AZ 85281 |
| Contact | Kristi M Kistner |
| Correspondent | Kristi M Kistner IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 Tempe, AZ 85281 |
| Product Code | DYF |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-26 |
| Decision Date | 1998-12-15 |
| Summary: | summary |