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FDA 510(k)

SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS

K-Number: K051312 · 2005-11-04

ApplicantVeryan Medical Limited
Decision Date2005-11-04
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS is the device name listed in this FDA 510(k) record. The listed applicant is Veryan Medical Limited. It received FDA 510(k) clearance on 2005-11-04 under 510(k) number K051312. 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 SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS?

SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS is a medical device that received FDA 510(k) clearance on 2005-11-04. The listed applicant is Veryan Medical Limited. The 510(k) number is K051312.

When did SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS receive FDA 510(k) clearance?

SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS received FDA 510(k) clearance on 2005-11-04, under 510(k) number K051312.

Who is the listed applicant for SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS?

The FDA 510(k) record lists Veryan Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS?

The FDA product code for SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS is DSY.

Related Clinical Trials

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.

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Other records listing Veryan Medical Limited 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.

K060741SWIRLGRAFT VASCULAR ACCESS GRAFT

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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