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FDA 510(k)

INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR

K-Number: K854845 · 1986-08-18

ApplicantIntervascular, Inc.
Decision Date1986-08-18
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR is the device name listed in this FDA 510(k) record. The listed applicant is Intervascular, Inc.. It received FDA 510(k) clearance on 1986-08-18 under 510(k) number K854845. 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 INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR?

INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR is a medical device that received FDA 510(k) clearance on 1986-08-18. The listed applicant is Intervascular, Inc.. The 510(k) number is K854845.

When did INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR receive FDA 510(k) clearance?

INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR received FDA 510(k) clearance on 1986-08-18, under 510(k) number K854845.

Who is the listed applicant for INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR?

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 INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR?

The FDA product code for INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR 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

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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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