FDA Product Code
FDA Product Code DYF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3450
510(k) Clearances — 21 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K004012 | IMPRA CARBOFLO EPTFE VASCULAR GRAFTS | Impra, Inc. | 2001-05-14 | Traditional | PDF ↗ |
| K000504 | ADVANTA SUPER SOFT GRAFT | Atrium Medical Corp. | 2000-03-01 | Special | PDF ↗ |
| K992958 | ADVANTA GRAFT (<6MM) | Atrium Medical Corp. | 1999-10-01 | Special | PDF ↗ |
| K991683 | PTFE RINGED GORE-TEX VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 1999-09-08 | Traditional | PDF ↗ |
| K992441 | ADVANTA GRAFT | Atrium Medical Corp. | 1999-08-20 | Special | PDF ↗ |
| K984183 | PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 | Possis Medical, Inc. | 1999-02-01 | Traditional | PDF ↗ |
| K983769 | DISTAFLO BYPASS GRAFT | Impra, Inc. | 1998-12-15 | Abbreviated | PDF ↗ |
| K981076 | VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT | Impra, Inc. | 1998-05-07 | Traditional | PDF ↗ |
| K964877 | IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT | Impra, Inc. | 1997-03-20 | Traditional | PDF ↗ |
| K960766 | MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT | Meadox Medicals, Div. Boston Scientific Corp. | 1997-03-19 | Traditional | PDF ↗ |
| K955533 | DIASTAT VASCULAR ACCESS GRAFT | W. L. Gore & Associates, Inc. | 1996-05-15 | Traditional | PDF ↗ |
| K953287 | DIASTAT VASCULAR ACCESS GRAFT | W. L. Gore & Associates, Inc. | 1995-10-06 | Traditional | PDF ↗ |
| K944844 | BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT | Baxter Healthcare Corp | 1995-03-31 | Traditional | PDF ↗ |
| K933391 | ATRIUM'S HYBRID PTFE | Atrium Medical Corp. | 1994-12-15 | Traditional | PDF ↗ |
| K940824 | DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III | W. L. Gore & Associates, Inc. | 1994-05-04 | Traditional | PDF ↗ |
| K934726 | FEP RINGED GORE-TEX VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 1993-12-08 | Traditional | PDF ↗ |
| K924360 | IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS) | Impra, Inc. | 1992-11-25 | Traditional | PDF ↗ |
| K881732 | GORE-TEX VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 1988-05-18 | Traditional | PDF ↗ |
| K842144 | GORE-TEX VASCULAR GRAFT, FEP-RINGED | W. L. Gore & Associates, Inc. | 1984-10-01 | Traditional | PDF ↗ |
| K821826 | FEP-RINGED GORE-TEX@ VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 1982-12-29 | Traditional | PDF ↗ |
| K791810 | VASCULAR GRAFT PROST. OF EXPANDED PTFE | Impra, Inc. | 1979-10-09 | Traditional | PDF ↗ |
Product code DYF · Class II · Cardiovascular. Data: openFDA.