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FDA PMA

Tissue graft of 6mm and greater

PMA Number: N16837 · 2026-09-04

ApplicantLeMaitre Vascular, Inc.
Decision Date2026-09-04
PMA NumberN16837
Product CodeLXA
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

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.

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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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