FDA PMA

Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Numéro PMA : P210027 · 2026-09-15

DemandeurBiosense Webster, Inc.

Date de décision2026-09-15

Numéro PMAP210027

Code produitOAE

Classe de dispositifClasse 3

Spécialité médicaleU

Comité consultatifCV

Résumé du dispositif

Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation is the device name listed in this FDA 510(k) record. The listed applicant is Biosense Webster, Inc.. It received FDA 510(k) clearance on 2026-09-15. The device is classified under product code OAE. It was reviewed by the CV advisory panel.

Questions fréquentes

What is the Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation?

Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation is a medical device that received FDA 510(k) clearance on 2026-09-15. The listed applicant is Biosense Webster, Inc..

When did Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation receive FDA 510(k) clearance?

The clearance date for Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation can be found in the official FDA records.

Who is the listed applicant for Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation?

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

What is the FDA product code for Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation?

The FDA product code for Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation is OAE.

Essais cliniques associés

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Source officielle

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