PCXNot classified

Artificial Chordae Tendinae Delivery System

Unknown

PCX is the FDA product code for Artificial Chordae Tendinae Delivery System. FDA's definition for this code reads: "Deploys ePTFE suture, labeled for use as artificial chordae tendinae, while the heart is beating as an alternative to the conventional surgical approach for this type of mitral valve repair". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PCX
Device name: Artificial Chordae Tendinae Delivery System
FDA definition: Deploys ePTFE suture, labeled for use as artificial chordae tendinae, while the heart is beating as an alternative to the conventional surgical approach for this type of mitral valve repair.
Device class: Not classified
Review panel: Unknown
Submission type: Contact ODE
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code PCX

FDA records hold no clearances under product code PCX.

Recent recalls

Product code PCX

FDA records show no recalls under product code PCX.

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)