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FDA PMA

Transcatheter septal occluder

PMA Number: P050006 · 2026-08-03

ApplicantW. L. Gore & Associates, Inc.
Decision Date2026-08-03
PMA NumberP050006
Product CodeMLV
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Transcatheter septal occluder 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 2026-08-03. The device is classified under product code MLV. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the Transcatheter septal occluder?

Transcatheter septal occluder is a medical device that received FDA 510(k) clearance on 2026-08-03. The listed applicant is W. L. Gore & Associates, Inc..

When did Transcatheter septal occluder receive FDA 510(k) clearance?

The clearance date for Transcatheter septal occluder can be found in the official FDA records.

Who is the listed applicant for Transcatheter septal occluder?

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 Transcatheter septal occluder?

The FDA product code for Transcatheter septal occluder is MLV.

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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