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FDA 510(k)

INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS

K-Number: K013651 · 2002-02-27

ApplicantIntervascular
Decision Date2002-02-27
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Intervascular. It received FDA 510(k) clearance on 2002-02-27 under 510(k) number K013651. 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 INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS?

INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS is a medical device that received FDA 510(k) clearance on 2002-02-27. The listed applicant is Intervascular. The 510(k) number is K013651.

When did INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS receive FDA 510(k) clearance?

INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS received FDA 510(k) clearance on 2002-02-27, under 510(k) number K013651.

Who is the listed applicant for INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS?

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

What is the FDA product code for INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS?

The FDA product code for INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS is DSY.

Related Clinical Trials

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Other records listing Intervascular 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.

K042984INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10CK022242INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER

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

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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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