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FDA 510(k)

SWIRLGRAFT VASCULAR ACCESS GRAFT

K-Number: K060741 · 2006-04-05

ApplicantVeryan Medical Limited
Decision Date2006-04-05
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SWIRLGRAFT VASCULAR ACCESS GRAFT 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 2006-04-05 under 510(k) number K060741. 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 VASCULAR ACCESS GRAFT?

SWIRLGRAFT VASCULAR ACCESS GRAFT is a medical device that received FDA 510(k) clearance on 2006-04-05. The listed applicant is Veryan Medical Limited. The 510(k) number is K060741.

When did SWIRLGRAFT VASCULAR ACCESS GRAFT receive FDA 510(k) clearance?

SWIRLGRAFT VASCULAR ACCESS GRAFT received FDA 510(k) clearance on 2006-04-05, under 510(k) number K060741.

Who is the listed applicant for SWIRLGRAFT VASCULAR ACCESS GRAFT?

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 VASCULAR ACCESS GRAFT?

The FDA product code for SWIRLGRAFT VASCULAR ACCESS GRAFT is DSY.

Related Clinical Trials

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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.

K051312SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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