OHA

FDA Product Code OHA: Heart Valve, More Than Minimally Manipulated Allograft

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.

Leading manufacturers include Artivion, Inc..

4
Total
4
Cleared
520d
Avg days
2008
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 93d recently vs 663d historically

FDA 510(k) Cleared Heart Valve, More Than Minimally Manipulated Allograft Devices (Product Code OHA)

4 devices
1–4 of 4
Cleared Oct 02, 2025
CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)
K252059
Artivion, Inc.
Cardiovascular · 93d

About Product Code OHA - Regulatory Context

510(k) Submission Activity

4 total 510(k) submissions under product code OHA since 2008, with 4 receiving FDA clearance (average review time: 520 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under OHA have taken an average of 93 days to reach a decision - down from 663 days historically, suggesting improved FDA processing for this classification.

OHA devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →