FDA product code DYF: Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
DYF is the FDA product code for prosthesis, vascular graft, of less then 6mm diameter. It is a Class II device, regulated under 21 CFR 870.3450 and reviewed by the Cardiovascular panel. FDA has cleared 21 510(k) submissions under DYF, from 6 different applicants. The average 510(k) review took 122 days (median 89). FDA has posted 17 recalls for DYF devices, 14 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter |
| Device class | Class II |
| Regulation | 21 CFR 870.3450 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every DYF clearance
Top DYF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| W. L. Gore & Associates, Inc. | 8 | 1999-09-08 |
| Impra, Inc. | 6 | 2001-05-14 |
| Atrium Medical Corp. | 4 | 2000-03-01 |
| Possis Medical, Inc. | 1 | 1999-02-01 |
| Meadox Medicals, Div. Boston Scientific Corp. | 1 | 1997-03-19 |
1 more applicants have DYF clearances. See the full list in Caduvo.
Most recent DYF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K004012 | Impra, Inc. | IMPRA CARBOFLO EPTFE VASCULAR GRAFTS | 2001-05-14 | 138 |
| K000504 | Atrium Medical Corp. | ADVANTA SUPER SOFT GRAFT | 2000-03-01 | 15 |
| K992958 | Atrium Medical Corp. | ADVANTA GRAFT (<6MM) | 1999-10-01 | 29 |
| K991683 | W. L. Gore & Associates, Inc. | PTFE RINGED GORE-TEX VASCULAR GRAFT | 1999-09-08 | 114 |
| K992441 | Atrium Medical Corp. | ADVANTA GRAFT | 1999-08-20 | 29 |
Recalls for DYF devices
17 product recalls in 2 recall events; 14 initiated in the last five years and 14 still open. Most recent: 2024-05-03.
| Year | Recalls |
|---|---|
| 2024 | 14 |
Frequently asked questions
What is FDA product code DYF?
DYF is the FDA product code for prosthesis, vascular graft, of less then 6mm diameter. It is a Class II device, regulated under 21 CFR 870.3450 and reviewed by the Cardiovascular panel.
What device class is DYF?
Class II, regulation 21 CFR 870.3450. Typical premarket route: 510(k).
How long does a 510(k) take for product code DYF?
Across 21 cleared submissions the average was 122 days from receipt to decision (median 89).
Which companies have the most DYF clearances?
W. L. Gore & Associates, Inc. (8); Impra, Inc. (6); Atrium Medical Corp. (4); Possis Medical, Inc. (1); Meadox Medicals, Div. Boston Scientific Corp. (1).
Have DYF devices been recalled?
Yes: 17 product recalls across 2 recall events; the most recent began 2024-05-03.
Next steps
- Run an FDA pathway report with predicate devices for product code DYF
- Run a recall and safety report across every DYF manufacturer
- Watch product code DYF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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