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FDA 510(k)

HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES

K-Number: K964625 · 1997-05-05

ApplicantIntervascular, Inc.
Decision Date1997-05-05
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES is the device name listed in this FDA 510(k) record. The listed applicant is Intervascular, Inc.. It received FDA 510(k) clearance on 1997-05-05 under 510(k) number K964625. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES?

HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES is a medical device that received FDA 510(k) clearance on 1997-05-05. The listed applicant is Intervascular, Inc.. The 510(k) number is K964625.

When did HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES receive FDA 510(k) clearance?

HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES received FDA 510(k) clearance on 1997-05-05, under 510(k) number K964625.

Who is the listed applicant for HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES?

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

What is the FDA product code for HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES?

The FDA product code for HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES is DSY.

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Other records listing Intervascular, 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.

K990800INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESISK984294MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESESK983819INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THINK970843INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESESK921659ULTRA LOW POROSITY DACRON WOVEN PATCHK913143OCHSNER ULP BIFURCATION VASCULAR PROTHESIS

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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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