DeviceClearance

Product code OHA— Unknown

CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)

Classification name
Heart Valve, More Than Minimally Manipulated Allograft
Device class
Unclassified
Advisory panel
Unknown
Total cleared
4
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OHA, via openFDA

Market context for product code OHA

FDA has cleared 4 devices under product code OHA between 2008 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code.

Clearances per year

Top applicants under product code OHA

Adverse events under product code OHA

product code OHA
Death
3
Total
3

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OHA

Data sourced from openFDA. This site is unofficial and independent of the FDA.