The following data is part of a premarket notification filed by Impra, Inc. with the FDA for Impra Flex Grafts (various Product Code Numbers).
| Device ID | K924360 |
| 510k Number | K924360 |
| Device Name: | IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS) |
| Classification | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter |
| Applicant | IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 Tempe, AZ 85281 |
| Contact | Joseph J Schwoebel |
| Correspondent | Joseph J Schwoebel IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 Tempe, AZ 85281 |
| Product Code | DYF |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Se - Postmarket Surveillance Required (SESP) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-28 |
| Decision Date | 1992-11-25 |