Cleared Traditional

K033484 - HUMAN HEART VALVE, CRYOVALVE SG (FDA 510(k) Clearance)

K033484 · Cryolife, Inc. · Cardiovascular device
Feb 2008
Decision
1556d
Days
-
Risk

K033484 is an FDA 510(k) clearance for the HUMAN HEART VALVE, CRYOVALVE SG. 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 7, 2008 after a review of 1556 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

Submission Details

510(k) Number K033484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2003
Decision Date February 07, 2008
Days to Decision 1556 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
1416d slower than avg
Panel avg: 140d · This submission: 1556d
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.