Cleared Traditional

K092021 - CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) (FDA 510(k) Clearance)

K092021 · Cryolife, Inc. · Cardiovascular device
May 2010
Decision
323d
Days
-
Risk

K092021 is an FDA 510(k) clearance for the CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT). Classified as Heart Valve, More Than Minimally Manipulated Allograft (product code OHA).

Submitted by Cryolife, Inc. (Kennesaw, US). The FDA issued a Cleared decision on May 25, 2010 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K092021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2009
Decision Date May 25, 2010
Days to Decision 323 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
183d slower than avg
Panel avg: 140d · This submission: 323d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OHA Heart Valve, More Than Minimally Manipulated Allograft
Device Class -
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.