Cleared Special

K252059 - CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) (FDA 510(k) Clearance)

K252059 · Artivion, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2025
Decision
93d
Days
-
Risk

K252059 is an FDA 510(k) clearance for the CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Condui.... Classified as Heart Valve, More Than Minimally Manipulated Allograft (product code OHA).

Submitted by Artivion, Inc. (Kennesaw, US). The FDA issued a Cleared decision on October 2, 2025 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Artivion, Inc. devices

Submission Details

510(k) Number K252059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2025
Decision Date October 02, 2025
Days to Decision 93 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 125d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

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.