PCX

Artificial Chordae Tendinae Delivery System

Product code: PCX
Device name: Artificial Chordae Tendinae Delivery System
Device class: Class N
Medical specialty: Unknown
Marketing pathway: Contact ODE

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: PCX

Classification and pathway per current FDA publications. Data from openFDA (CC0).