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FDA PMA

Tissue graft of 6mm and greater

Número do PMA: N16837 · 2026-09-04

RequerenteLeMaitre Vascular, Inc.
Data da decisão2026-09-04
Número PMAN16837
Código do produtoLXA
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoCV

Resumo do dispositivo

Tissue graft of 6mm and greater is the device name listed in this FDA 510(k) record. The listed applicant is LeMaitre Vascular, Inc.. It received FDA 510(k) clearance on 2026-09-04. The device is classified under product code LXA. It was reviewed by the CV advisory panel.

Perguntas frequentes

What is the Tissue graft of 6mm and greater?

Tissue graft of 6mm and greater is a medical device that received FDA 510(k) clearance on 2026-09-04. The listed applicant is LeMaitre Vascular, Inc..

When did Tissue graft of 6mm and greater receive FDA 510(k) clearance?

The clearance date for Tissue graft of 6mm and greater can be found in the official FDA records.

Who is the listed applicant for Tissue graft of 6mm and greater?

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

What is the FDA product code for Tissue graft of 6mm and greater?

The FDA product code for Tissue graft of 6mm and greater is LXA.

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Fonte oficial

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