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FDA 510(k)

VASCUTEK GRAFT SIZER SET

K-Number: K955588 · 1996-03-07

ApplicantCarbomedics, Inc.
Decision Date1996-03-07
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

VASCUTEK GRAFT SIZER SET is the device name listed in this FDA 510(k) record. The listed applicant is Carbomedics, Inc.. It received FDA 510(k) clearance on 1996-03-07 under 510(k) number K955588. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the VASCUTEK GRAFT SIZER SET?

VASCUTEK GRAFT SIZER SET is a medical device that received FDA 510(k) clearance on 1996-03-07. The listed applicant is Carbomedics, Inc.. The 510(k) number is K955588.

When did VASCUTEK GRAFT SIZER SET receive FDA 510(k) clearance?

VASCUTEK GRAFT SIZER SET received FDA 510(k) clearance on 1996-03-07, under 510(k) number K955588.

Who is the listed applicant for VASCUTEK GRAFT SIZER SET?

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 GRAFT SIZER SET?

The FDA product code for VASCUTEK GRAFT SIZER SET is DSY.

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Other records listing Carbomedics, Inc. as applicant

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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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