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FDA PMA

System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

Número do PMA: P130006 · 2026-05-26

RequerenteW. L. Gore & Associates, Inc.
Data da decisão2026-05-26
Número PMAP130006
Código do produtoPFV
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoCV

Resumo do dispositivo

System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2026-05-26. The device is classified under product code PFV. It was reviewed by the CV advisory panel.

Perguntas frequentes

What is the System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment?

System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment is a medical device that received FDA 510(k) clearance on 2026-05-26. The listed applicant is W. L. Gore & Associates, Inc..

When did System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment receive FDA 510(k) clearance?

The clearance date for System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment can be found in the official FDA records.

Who is the listed applicant for System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment?

The FDA product code for System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment is PFV.

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Fonte oficial

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