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FDA PMA

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

PMA Number: P150026 · 2023-08-11

ApplicantCardiofocus, Inc.
Decision Date2023-08-11
PMA NumberP150026
Product CodeOAE
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation is the device name listed in this FDA 510(k) record. The listed applicant is Cardiofocus, Inc.. It received FDA 510(k) clearance on 2023-08-11. The device is classified under product code OAE. It was reviewed by the CV advisory panel.

Frequently Asked Questions

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 2023-08-11. The listed applicant is Cardiofocus, 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 Cardiofocus, 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.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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