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FDA PMA

Transcatheter septal occluder (atrial)

PMA Number: P200032 · 2026-06-05

ApplicantOcclutech Holding AG
Decision Date2026-06-05
PMA NumberP200032
Product CodeOZG
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Transcatheter septal occluder (atrial) is the device name listed in this FDA 510(k) record. The listed applicant is Occlutech Holding AG. It received FDA 510(k) clearance on 2026-06-05. The device is classified under product code OZG. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the Transcatheter septal occluder (atrial)?

Transcatheter septal occluder (atrial) is a medical device that received FDA 510(k) clearance on 2026-06-05. The listed applicant is Occlutech Holding AG.

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

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

Who is the listed applicant for Transcatheter septal occluder (atrial)?

The FDA 510(k) record lists Occlutech Holding AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transcatheter septal occluder (atrial)?

The FDA product code for Transcatheter septal occluder (atrial) is OZG.

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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