Heart Valve, More Than Minimally Manipulated Allograft

OHA · Unclassified · Unknown

Classification

FDA Product Code: OHA
Device class: Unclassified
Regulation: —
Review panel: CV
Medical specialty: Unknown
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

For the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary heart valves. They may also be used in the replacement of native pulmonary heart valves when the ross procedure is performed. Pulmonary heart valve allografts are used to repair both congential and acquired valvular lesions.

Market data

Cleared 510(k) submissions: 4
Registered establishments: 2

Source

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