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FDA PMA

Cardiac ablation percutaneous catheter

PMA Number: P990071 · 2025-12-23

ApplicantBiosense Webster, Inc.
Decision Date2025-12-23
PMA NumberP990071
Product CodeLPB
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Cardiac ablation percutaneous catheter 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 2025-12-23. The device is classified under product code LPB. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the Cardiac ablation percutaneous catheter?

Cardiac ablation percutaneous catheter is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Biosense Webster, Inc..

When did Cardiac ablation percutaneous catheter receive FDA 510(k) clearance?

The clearance date for Cardiac ablation percutaneous catheter can be found in the official FDA records.

Who is the listed applicant for Cardiac ablation percutaneous catheter?

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 Cardiac ablation percutaneous catheter?

The FDA product code for Cardiac ablation percutaneous catheter is LPB.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Official Source

View on FDA Database →

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

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