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FDA 510(k)

LOW POROSITY (LP) VASCULAR PROSTHESIS

K-Number: K912911 · 1991-09-23

ApplicantIntervascular, Inc.
Decision Date1991-09-23
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LOW POROSITY (LP) VASCULAR PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Intervascular, Inc.. It received FDA 510(k) clearance on 1991-09-23 under 510(k) number K912911. 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 LOW POROSITY (LP) VASCULAR PROSTHESIS?

LOW POROSITY (LP) VASCULAR PROSTHESIS is a medical device that received FDA 510(k) clearance on 1991-09-23. The listed applicant is Intervascular, Inc.. The 510(k) number is K912911.

When did LOW POROSITY (LP) VASCULAR PROSTHESIS receive FDA 510(k) clearance?

LOW POROSITY (LP) VASCULAR PROSTHESIS received FDA 510(k) clearance on 1991-09-23, under 510(k) number K912911.

Who is the listed applicant for LOW POROSITY (LP) VASCULAR PROSTHESIS?

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 LOW POROSITY (LP) VASCULAR PROSTHESIS?

The FDA product code for LOW POROSITY (LP) VASCULAR PROSTHESIS 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 PROSTHESESK964625HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESESK921659ULTRA LOW POROSITY DACRON WOVEN PATCH

View all 16 devices →

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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