LXNClass I

Probe, Test, Heart-Valve

21 CFR 870.4500 / Cardiovascular

LXN is the FDA product code for Probe, Test, Heart-Valve, a class I device type, regulated under 21 CFR 870.4500. As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 1989-02-13, and no recalls.

Classification record

Product code: LXN
Device name: Probe, Test, Heart-Valve
Regulation: 21 CFR 870.4500
Device class: Class I
Review panel: Cardiovascular
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code LXN

By decision year

2 clearances under product code LXN with a decision year between 1988 and 1989, 1988 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code LXN by decision year
Year	Clearances
1988	1
1989	1

Applicants with the most clearances

Product code LXN

Applicants holding the most 510(k) clearances under product code LXN
Applicant	Clearances
Baxter Healthcare Corporation	1
Dhason Brothers, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code LXN

Recent recalls

Product code LXN

FDA records show no recalls under product code LXN.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)