The following data is part of a premarket notification filed by Impra, Inc. with the FDA for Bi-directional Tunneler.
| Device ID | K991027 |
| 510k Number | K991027 |
| Device Name: | BI-DIRECTIONAL TUNNELER |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater 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 | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-29 |
| Decision Date | 1999-04-22 |
| Summary: | summary |