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FDA 510(k)

OCHSNER 50 BIFURCATION

K-Number: K903964 · 1990-12-03

ApplicantIntervascular, Inc.
Decision Date1990-12-03
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OCHSNER 50 BIFURCATION is the device name listed in this FDA 510(k) record. The listed applicant is Intervascular, Inc.. It received FDA 510(k) clearance on 1990-12-03 under 510(k) number K903964. 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 50 BIFURCATION?

OCHSNER 50 BIFURCATION is a medical device that received FDA 510(k) clearance on 1990-12-03. The listed applicant is Intervascular, Inc.. The 510(k) number is K903964.

When did OCHSNER 50 BIFURCATION receive FDA 510(k) clearance?

OCHSNER 50 BIFURCATION received FDA 510(k) clearance on 1990-12-03, under 510(k) number K903964.

Who is the listed applicant for OCHSNER 50 BIFURCATION?

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 50 BIFURCATION?

The FDA product code for OCHSNER 50 BIFURCATION 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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