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
K881449Substantially Equivalent

Edwards-Duromedics Leaflet Probe, Model 1116

Baxter Healthcare Corporation, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881449 is the FDA 510(k) clearance record for EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116, a class I device, cleared for Baxter Healthcare Corp on under FDA product code LXN (Probe, Test, Heart-Valve). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K881449.

Clearance record

Decision date
Received
(71 days to decision)
Product code
LXN Probe, Test, Heart-Valve
Regulation
21 CFR 870.4500
Device class
Class I
Review panel
Cardiovascular
Applicant
Baxter Healthcare Corp P O Box 11150, Santa Ana CA
Third party review
No

Clearances, product code LXN

Trailing 12 months

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

FDA records show no clearances under product code LXN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LXN, 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