510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092021Substantially Equivalent

Cryovalve Sg Pulmonary Human Heart Valve (and Conduit)

Artivion, Inc., Kennesaw GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092021 is the FDA 510(k) clearance record for CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT), cleared for Cryolife, Inc. on under FDA product code OHA (Heart Valve, More Than Minimally Manipulated Allograft). FDA's definition for product code OHA 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...". FDA records list 13 510(k) clearances for Artivion, Inc., from to . As of , FDA records show 5 recalls naming K092021.

Clearance record

Decision date
Received
(323 days to decision)
Product code
OHA Heart Valve, More Than Minimally Manipulated Allograft
Device class
Unclassified
Review panel
Unknown
Applicant
Cryolife, Inc. 1655 Roberts Blvd. NW, Kennesaw GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OHA

Trailing 12 months

FDA records hold no clearances under product code OHA in the trailing twelve months.

FDA records show no clearances under product code OHA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OHA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260