510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981076Substantially Equivalent

Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular Graft

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

K981076 is the FDA 510(k) clearance record for VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT, 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 K981076.

Clearance record

Decision date
Received
(44 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