510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OHAUnclassified

Heart Valve, More Than Minimally Manipulated Allograft

Unknown
FDA source (opens on fda.gov)

OHA is the FDA product code for Heart Valve, More Than Minimally Manipulated Allograft. FDA's definition for this code reads: "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...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
OHA
Device name
Heart Valve, More Than Minimally Manipulated Allograft
FDA 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.
Device class
Unclassified
Review panel
Unknown
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
4

Clearances, product code OHA

By decision year
4 clearances under product code OHA with a decision year between 2008 and 2025, 2008 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OHA by decision year
YearClearances
20081
20091
20101
20251

Applicants with the most clearances

Product code OHA
Applicants holding the most 510(k) clearances under product code OHA
ApplicantClearances
Artivion, Inc.4

Companies listing this code with FDA

Companies whose registered establishments list this code