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FDA 510(k)

HERO GRAFT

K-Number: K120006 · 2012-02-02

ApplicantHemosphere, Inc.
Decision Date2012-02-02
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 Hemosphere, Inc.. It received FDA 510(k) clearance on 2012-02-02 under 510(k) number K120006. 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 2012-02-02. The listed applicant is Hemosphere, Inc.. The 510(k) number is K120006.

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

HERO GRAFT received FDA 510(k) clearance on 2012-02-02, under 510(k) number K120006.

Who is the listed applicant for HERO GRAFT?

The FDA 510(k) record lists Hemosphere, Inc. 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.

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.

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Other records listing Hemosphere, 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.

K121532HERO GRAFTK091491HERO VASCULAR ACCESS DEVICE

Related Devices (Code: DSY)

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.

K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLCK252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies LimitedK241550Gelweave™ Vascular ProsthesesVascutek, Ltd.K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical CorporationK240083GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, 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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