Cleared Traditional

K083106 - CRYOVALVE SG PULMONARY VALVE AND CONDUIT (FDA 510(k) Clearance)

K083106 · Cryolife, Inc. · Cardiovascular device
Feb 2009
Decision
109d
Days
-
Risk

K083106 is an FDA 510(k) clearance for the CRYOVALVE SG PULMONARY 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 February 6, 2009 after a review of 109 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 K083106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2008
Decision Date February 06, 2009
Days to Decision 109 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 140d · This submission: 109d
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.