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FDA 510(k)

SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS

K-Number: K993667 · 2000-01-28

ApplicantSulzermedica
Decision Date2000-01-28
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Sulzermedica. It received FDA 510(k) clearance on 2000-01-28 under 510(k) number K993667. 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 SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS?

SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS is a medical device that received FDA 510(k) clearance on 2000-01-28. The listed applicant is Sulzermedica. The 510(k) number is K993667.

When did SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS receive FDA 510(k) clearance?

SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS received FDA 510(k) clearance on 2000-01-28, under 510(k) number K993667.

Who is the listed applicant for SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS?

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

What is the FDA product code for SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS?

The FDA product code for SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS is DSY.

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Other records listing Sulzermedica 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.

K002324MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMAK990503SULZER VASCUTEK GELSOFT VASCULAR PROSTHESISK993569APR METASUL ACETABULAR INSERTK992832SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS

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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