510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DYFClass II

Prosthesis, Vascular Graft, Of Less Then 6mm Diameter

21 CFR 870.3450 / Cardiovascular
FDA source (opens on fda.gov)

DYF is the FDA product code for Prosthesis, Vascular Graft, Of Less Then 6mm Diameter, a class II device type, regulated under 21 CFR 870.3450. As of , FDA records hold 21 510(k) clearances under this code, the most recent dated , and 17 recalls.

Classification record

Product code
DYF
Device name
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Regulation
21 CFR 870.3450
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
21
Ingested recalls
17

Clearances, product code DYF

By decision year
21 clearances under product code DYF with a decision year between 1979 and 2001, 1999 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code DYF by decision year
YearClearances
19791
19821
19841
19881
19921
19931
19942
19952
19961
19972
19982
19994
20001
20011

Applicants with the most clearances

Product code DYF
Applicants holding the most 510(k) clearances under product code DYF
ApplicantClearances
W. L. Gore & Associates, Inc.8
Impra, Inc.5
Atrium Medical Corporation4
Baxter Healthcare Corporation1
Impra, Inc.1
Meadox Medicals, Div. Boston Scientific Corp.1
Possis Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code