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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 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.

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. 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07089576Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSARECRUITINGNCT02744677COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve DysfunctionRECRUITING

Other records listing Artivion, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P250055Hybrid stent graft, thoracic aortic lesion treatment

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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