Artificial Chordae Tendinae Delivery System

PCX · Not classified · Unknown

Classification

FDA Product Code: PCX
Device class: Not classified
Regulation: —
Review panel: CV
Medical specialty: Unknown
Submission type: 3
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown