FDA 510(k)

CryoValve SG 肺動脈弁（SGPV10）CryoValve SG 肺動脈弁および導管（SGPV00）

K番号: K252059 · 2025-10-02

決定日2025-10-02

製品コードOHA

決定大幅同等

医療機器の概要

CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) is the device name listed in this FDA 510(k) record. The listed applicant is Artivion, Inc.. It received FDA 510(k) clearance on 2025-10-02 under 510(k) number K252059. The device is classified under product code OHA. FDA Decision: Substantially Equivalent.

よくある質問

What is the CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)?

CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) is a medical device that received FDA 510(k) clearance on 2025-10-02. The listed applicant is Artivion, Inc.. The 510(k) number is K252059.

When did CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) receive FDA 510(k) clearance?

CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) received FDA 510(k) clearance on 2025-10-02, under 510(k) number K252059.

Who is the listed applicant for CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)?

The FDA 510(k) record lists Artivion, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)?

The FDA product code for CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) is OHA.

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医療機器の概要

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