DYF · Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Cardiovascular · 21 CFR 870.3450 · Class 2
Overview
| Product Code | DYF |
|---|---|
| Device Name | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter |
| Regulation | 21 CFR 870.3450 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Implant | Yes |
Identification
A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”
Recent Cleared Devices (20 of 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K004012 | IMPRA CARBOFLO EPTFE VASCULAR GRAFTS | Impra, Inc. | May 14, 2001 | SESE |
| K000504 | ADVANTA SUPER SOFT GRAFT | Atrium Medical Corp. | Mar 1, 2000 | SESE |
| K992958 | ADVANTA GRAFT (<6MM) | Atrium Medical Corp. | Oct 1, 1999 | SESE |
| K991683 | PTFE RINGED GORE-TEX VASCULAR GRAFT | W. L. Gore & Associates, Inc. | Sep 8, 1999 | SESE |
| K992441 | ADVANTA GRAFT | Atrium Medical Corp. | Aug 20, 1999 | SESE |
| K984183 | PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 | Possis Medical, Inc. | Feb 1, 1999 | SESE |
| K983769 | DISTAFLO BYPASS GRAFT | Impra, Inc. | Dec 15, 1998 | SESE |
| K981076 | VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT | Impra, Inc. | May 7, 1998 | SESE |
| K964877 | IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT | Impra, Inc. | Mar 20, 1997 | ST |
| K960766 | MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT | Meadox Medicals, Div. Boston Scientific Corp. | Mar 19, 1997 | ST |
| K955533 | DIASTAT VASCULAR ACCESS GRAFT | W. L. Gore & Associates, Inc. | May 15, 1996 | ST |
| K953287 | DIASTAT VASCULAR ACCESS GRAFT | W. L. Gore & Associates, Inc. | Oct 6, 1995 | ST |
| K944844 | BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT | Baxter Healthcare Corp | Mar 31, 1995 | SESP |
| K933391 | ATRIUM'S HYBRID PTFE | Atrium Medical Corp. | Dec 15, 1994 | SESP |
| K940824 | DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III | W. L. Gore & Associates, Inc. | May 4, 1994 | PT |
| K934726 | FEP RINGED GORE-TEX VASCULAR GRAFT | W. L. Gore & Associates, Inc. | Dec 8, 1993 | SESE |
| K924360 | IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS) | Impra, Inc. | Nov 25, 1992 | SESP |
| K881732 | GORE-TEX VASCULAR GRAFT | W. L. Gore & Associates, Inc. | May 18, 1988 | SESE |
| K842144 | GORE-TEX VASCULAR GRAFT, FEP-RINGED | W. L. Gore & Associates, Inc. | Oct 1, 1984 | SESE |
| K821826 | FEP-RINGED GORE-TEX@ VASCULAR GRAFT | W. L. Gore & Associates, Inc. | Dec 29, 1982 | SESE |
Top Applicants
- W. L. Gore & Associates, Inc. — 8 clearances
- Impra, Inc. — 6 clearances
- Atrium Medical Corp. — 4 clearances
- Baxter Healthcare Corp — 1 clearance
- Meadox Medicals, Div. Boston Scientific Corp. — 1 clearance
