510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K944844Unknown

Baxter Reinforced Expanded PTFE Stepped Vascular Graft

Baxter Healthcare Corporation, Irvine CA / Traditional, Unknown
FDA source (opens on fda.gov)

K944844 is the FDA 510(k) clearance record for BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT, a class II device, cleared for Baxter Healthcare Corp on under FDA product code DYF (Prosthesis, Vascular Graft, Of Less Then 6mm Diameter). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K944844.

Clearance record

Decision date
Received
(182 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
Baxter Healthcare Corp 17221 Red Hill Ave., Irvine CA
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DYF, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260