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FDA PMA

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

PMA Number: P010068 · 2025-02-26

ApplicantBiosense Webster, Inc.
Decision Date2025-02-26
PMA NumberP010068
Product CodeOAD
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

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 2025-02-26. The device is classified under product code OAD. It was reviewed by the CV advisory panel.

Frequently Asked Questions

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 2025-02-26. 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.

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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