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FDA 510(k)

VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT

K-Number: K960706 · 1996-04-25

ApplicantCarbomedics, Inc.
Decision Date1996-04-25
Product CodeDSY
Advisory CommitteeCV
DecisionUnknown

Device Summary

VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Carbomedics, Inc.. It received FDA 510(k) clearance on 1996-04-25 under 510(k) number K960706. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT?

VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT is a medical device that received FDA 510(k) clearance on 1996-04-25. The listed applicant is Carbomedics, Inc.. The 510(k) number is K960706.

When did VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT receive FDA 510(k) clearance?

VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT received FDA 510(k) clearance on 1996-04-25, under 510(k) number K960706.

Who is the listed applicant for VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT?

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

What is the FDA product code for VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT?

The FDA product code for VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT is DSY.

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Other records listing Carbomedics, 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.

K970375ANNULOFLO SYSTEMK964665VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)K962154CARBOMEDICS HANDLEK960923CARBOMEDICS MITRAL ROTATORK960169CARBOMEDICS VALVE TESTERK955588VASCUTEK GRAFT SIZER SET

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Related Devices (Code: DSY)

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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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