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FDA PMA

Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

Numéro PMA : P230030 · 2026-09-04

DemandeurFarapulse, Inc.
Date de décision2026-09-04
Numéro PMAP230030
Code produitQZI
Classe de dispositifClasse 3
Spécialité médicaleU
Comité consultatifCV

Résumé du dispositif

Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation is the device name listed in this FDA 510(k) record. The listed applicant is Farapulse, Inc.. It received FDA 510(k) clearance on 2026-09-04. The device is classified under product code QZI. It was reviewed by the CV advisory panel.

Questions fréquentes

What is the Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation?

Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation is a medical device that received FDA 510(k) clearance on 2026-09-04. The listed applicant is Farapulse, Inc..

When did Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation receive FDA 510(k) clearance?

The clearance date for Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation can be found in the official FDA records.

Who is the listed applicant for Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation?

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

What is the FDA product code for Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation?

The FDA product code for Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation is QZI.

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Source officielle

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