DYF — Prosthesis, Vascular Graft, Of Less Then 6mm Diameter Class II
FDA product code DYF covers "Prosthesis, Vascular Graft, Of Less Then 6mm Diameter", a Class II medical device regulated under 21 CFR 870.3450. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DYF
- Device Class
- Class II
- Regulation Number
- 870.3450
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K004012 | impra | IMPRA CARBOFLO EPTFE VASCULAR GRAFTS | May 14, 2001 |
| K000504 | atrium medical | ADVANTA SUPER SOFT GRAFT | March 1, 2000 |
| K992958 | atrium medical | ADVANTA GRAFT (<6MM) | October 1, 1999 |
| K991683 | w. l. gore and associates | PTFE RINGED GORE-TEX VASCULAR GRAFT | September 8, 1999 |
| K992441 | atrium medical | ADVANTA GRAFT | August 20, 1999 |
| K984183 | possis medical | PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 | February 1, 1999 |
| K983769 | impra | DISTAFLO BYPASS GRAFT | December 15, 1998 |
| K981076 | impra | VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT | May 7, 1998 |
| K964877 | impra | IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT | March 20, 1997 |
| K960766 | meadox medicals, div. boston scientific | MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT | March 19, 1997 |
| K955533 | w. l. gore and associates | DIASTAT VASCULAR ACCESS GRAFT | May 15, 1996 |
| K953287 | w. l. gore and associates | DIASTAT VASCULAR ACCESS GRAFT | October 6, 1995 |
| K944844 | baxter healthcare | BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT | March 31, 1995 |
| K933391 | atrium medical | ATRIUM'S HYBRID PTFE | December 15, 1994 |
| K940824 | w. l. gore and associates | DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III | May 4, 1994 |
| K934726 | w. l. gore and associates | FEP RINGED GORE-TEX VASCULAR GRAFT | December 8, 1993 |
| K924360 | impra | IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS) | November 25, 1992 |
| K881732 | w. l. gore and associates | GORE-TEX VASCULAR GRAFT | May 18, 1988 |
| K842144 | w. l. gore and associates | GORE-TEX VASCULAR GRAFT, FEP-RINGED | October 1, 1984 |
| K821826 | w. l. gore and associates | FEP-RINGED GORE-TEX@ VASCULAR GRAFT | December 29, 1982 |