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FDA 510(k)

OCHSNER 500 VASCULAR PROSTHESIS

K-Number: K905269 · 1991-04-02

ApplicantIntervascular, Inc.
Decision Date1991-04-02
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OCHSNER 500 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 1991-04-02 under 510(k) number K905269. 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 OCHSNER 500 VASCULAR PROSTHESIS?

OCHSNER 500 VASCULAR PROSTHESIS is a medical device that received FDA 510(k) clearance on 1991-04-02. The listed applicant is Intervascular, Inc.. The 510(k) number is K905269.

When did OCHSNER 500 VASCULAR PROSTHESIS receive FDA 510(k) clearance?

OCHSNER 500 VASCULAR PROSTHESIS received FDA 510(k) clearance on 1991-04-02, under 510(k) number K905269.

Who is the listed applicant for OCHSNER 500 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 OCHSNER 500 VASCULAR PROSTHESIS?

The FDA product code for OCHSNER 500 VASCULAR PROSTHESIS is DSY.

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Other records listing Intervascular, Inc. as applicant

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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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