510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K004012Substantially Equivalent

Impra Carboflo Eptfe Vascular Grafts

Impra, Inc., Tempe AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K004012 is the FDA 510(k) clearance record for IMPRA CARBOFLO EPTFE VASCULAR GRAFTS, a class II device, cleared for Impra, Inc. on under FDA product code DYF (Prosthesis, Vascular Graft, Of Less Then 6mm Diameter). FDA records list 24 510(k) clearances for Impra, Inc., from to . As of , FDA records show no recalls naming K004012.

Clearance record

Decision date
Received
(138 days to decision)
Product code
DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Regulation
21 CFR 870.3450
Device class
Class II
Review panel
Cardiovascular
Applicant
Impra, Inc. 1625 W. 3rd St., Tempe AZ
510(k) summary
Summary
Third party review
No

Clearances, product code DYF

Trailing 12 months

FDA records hold no clearances under product code DYF in the trailing twelve months.

FDA records show no clearances under product code DYF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DYF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260