MNOClass III

System, Laser, Transmyocardial Revascularization

Unknown

MNO is the FDA product code for System, Laser, Transmyocardial Revascularization, a class III device type. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: MNO
Device name: System, Laser, Transmyocardial Revascularization
Device class: Class III
Review panel: Unknown
Submission type: PMA
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

Sterigenics U.S., LLC

Recent clearances

Product code MNO

FDA records hold no clearances under product code MNO.

Recent recalls

Product code MNO

Z-1993-2013Class IIFollowing acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the...Cardiogenesis Corporation / initiated 2011-05-01 / 2498

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)