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FDA 510(k)

ULTRAMAX WOVEN VELOUR VASCULAR GRAFT

K-Number: K013577 · 2002-01-25

ApplicantAtrium Medical Corp.
Decision Date2002-01-25
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ULTRAMAX WOVEN VELOUR VASCULAR GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Atrium Medical Corp.. It received FDA 510(k) clearance on 2002-01-25 under 510(k) number K013577. 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 ULTRAMAX WOVEN VELOUR VASCULAR GRAFT?

ULTRAMAX WOVEN VELOUR VASCULAR GRAFT is a medical device that received FDA 510(k) clearance on 2002-01-25. The listed applicant is Atrium Medical Corp.. The 510(k) number is K013577.

When did ULTRAMAX WOVEN VELOUR VASCULAR GRAFT receive FDA 510(k) clearance?

ULTRAMAX WOVEN VELOUR VASCULAR GRAFT received FDA 510(k) clearance on 2002-01-25, under 510(k) number K013577.

Who is the listed applicant for ULTRAMAX WOVEN VELOUR VASCULAR GRAFT?

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

What is the FDA product code for ULTRAMAX WOVEN VELOUR VASCULAR GRAFT?

The FDA product code for ULTRAMAX WOVEN VELOUR VASCULAR GRAFT is DSY.

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Other records listing Atrium Medical Corp. 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.

K130131EDRAIN CHEST DRAINAGE SYSTEMK122138ATRIUM FLIXENE IFG VASCULAR GRAFTK121070C-QUR RPM MESHK113112CLEARWAY RX NB CATHETERK102596ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFTK093431CLEARWAY OTW MODEL 85912

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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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