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FDA 510(k)

HUMAN HEART VALVE, CRYOVALVE SG

K-Number: K033484 · 2008-02-07

ApplicantCryolife, Inc.
Decision Date2008-02-07
Product CodeOHA
DecisionSubstantially Equivalent

Device Summary

HUMAN HEART VALVE, CRYOVALVE SG is the device name listed in this FDA 510(k) record. The listed applicant is Cryolife, Inc.. It received FDA 510(k) clearance on 2008-02-07 under 510(k) number K033484. The device is classified under product code OHA. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAN HEART VALVE, CRYOVALVE SG?

HUMAN HEART VALVE, CRYOVALVE SG is a medical device that received FDA 510(k) clearance on 2008-02-07. The listed applicant is Cryolife, Inc.. The 510(k) number is K033484.

When did HUMAN HEART VALVE, CRYOVALVE SG receive FDA 510(k) clearance?

HUMAN HEART VALVE, CRYOVALVE SG received FDA 510(k) clearance on 2008-02-07, under 510(k) number K033484.

Who is the listed applicant for HUMAN HEART VALVE, CRYOVALVE SG?

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

What is the FDA product code for HUMAN HEART VALVE, CRYOVALVE SG?

The FDA product code for HUMAN HEART VALVE, CRYOVALVE SG is OHA.

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Other records listing Cryolife, 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.

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Related Devices (Code: OHA)

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.

K252059CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)Artivion, Inc.K092021CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)Cryolife, Inc.K083106CRYOVALVE SG PULMONARY VALVE AND CONDUITCryolife, Inc.

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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