FDA 510(k)

exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts

Номер K: K233783 · 2024-01-17

Дата решения2024-01-17

Код продуктаDSY

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts is the device name listed in this FDA 510(k) record. The listed applicant is Peca Labs, Inc.. It received FDA 510(k) clearance on 2024-01-17 under 510(k) number K233783. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts?

exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts is a medical device that received FDA 510(k) clearance on 2024-01-17. The listed applicant is Peca Labs, Inc.. The 510(k) number is K233783.

When did exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts receive FDA 510(k) clearance?

exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts received FDA 510(k) clearance on 2024-01-17, under 510(k) number K233783.

Who is the listed applicant for exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts?

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

What is the FDA product code for exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts?

The FDA product code for exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts is DSY.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: DSY)

K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC K252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies Limited K241550Gelweave™ Vascular ProsthesesVascutek, Ltd.K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical Corporation K240083GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc.

Официальный источник

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