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FDA 510(k)

HERO GRAFT

K-Number: K124039 · 2013-03-07

ApplicantHemoshpere, Inc., A Cryolife Company
Decision Date2013-03-07
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HERO GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Hemoshpere, Inc., A Cryolife Company. It received FDA 510(k) clearance on 2013-03-07 under 510(k) number K124039. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HERO GRAFT?

HERO GRAFT is a medical device that received FDA 510(k) clearance on 2013-03-07. The listed applicant is Hemoshpere, Inc., A Cryolife Company. The 510(k) number is K124039.

When did HERO GRAFT receive FDA 510(k) clearance?

HERO GRAFT received FDA 510(k) clearance on 2013-03-07, under 510(k) number K124039.

Who is the listed applicant for HERO GRAFT?

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

What is the FDA product code for HERO GRAFT?

The FDA product code for HERO GRAFT is DSY.

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Related Devices (Code: DSY)

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Official Source

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

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