510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K944858Substantially Equivalent - Subject to Tracking Reg.

Baxter Eptfe Externally Supported Vascular Grafts

Baxter Edwards, Irvine CA / Traditional, Substantially Equivalent - Subject to Tracking Reg.
FDA source (opens on fda.gov)

K944858 is the FDA 510(k) clearance record for BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS, a class II device, cleared for Baxter Edwards on under FDA product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter). FDA records list 11 510(k) clearances for Baxter Edwards, from to . As of , FDA records show no recalls naming K944858.

Clearance record

Decision date
Received
(94 days to decision)
Product code
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Regulation
21 CFR 870.3450
Device class
Class II
Review panel
Cardiovascular
Applicant
Baxter Edwards 17221 Red Hill Ave., Irvine CA
Third party review
No

Clearances, product code DSY

Trailing 12 months
1 clearance under product code DSY in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260