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FDA PMA

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Número do PMA: P030031 · 2026-09-15

RequerenteBiosense Webster, Inc.
Data da decisão2026-09-15
Número PMAP030031
Código do produtoOAD
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoCV

Resumo do dispositivo

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter 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 OAD. It was reviewed by the CV advisory panel.

Perguntas frequentes

What is the catheter, percutaneous, cardiac ablation, for treatment of atrial flutter?

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter 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 flutter receive FDA 510(k) clearance?

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

Who is the listed applicant for catheter, percutaneous, cardiac ablation, for treatment of atrial flutter?

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 flutter?

The FDA product code for catheter, percutaneous, cardiac ablation, for treatment of atrial flutter is OAD.

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