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FDA 510(k)

CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)

K-Number: K252059 · 2025-10-02

ApplicantArtivion, Inc.
Decision Date2025-10-02
Product CodeOHA
DecisionSubstantially Equivalent

Device Summary

CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) is a medical device manufactured by Artivion, Inc.. It received FDA 510(k) clearance on 2025-10-02 under approval number K252059. The device is classified under product code OHA. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Artivion, Inc.. The 510(k) number is K252059.

When was CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) approved by the FDA?

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

What company makes 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 manufactured by Artivion, Inc..

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.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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