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FDA PMA

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

Numéro PMA : P060019 · 2026-08-07

DemandeurIrvine Biomedical, Inc.
Date de décision2026-08-07
Numéro PMAP060019
Code produitOAD
Classe de dispositifClasse 3
Spécialité médicaleU
Comité consultatifCV

Résumé du dispositif

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter is the device name listed in this FDA 510(k) record. The listed applicant is Irvine Biomedical, Inc.. It received FDA 510(k) clearance on 2026-08-07. The device is classified under product code OAD. It was reviewed by the CV advisory panel.

Questions fréquentes

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 2026-08-07. The listed applicant is Irvine Biomedical, 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 Irvine Biomedical, 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.

Essais cliniques associés

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Source officielle

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