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FDA 510(k)

AblatePal Radiofrequency Ablation System

K-Number: K223135 · 2023-06-30

ApplicantCompal Electronics, Inc.
Decision Date2023-06-30
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AblatePal Radiofrequency Ablation System is a medical device manufactured by Compal Electronics, Inc.. It received FDA 510(k) clearance on 2023-06-30 under approval number K223135. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AblatePal Radiofrequency Ablation System?

AblatePal Radiofrequency Ablation System is a medical device that received FDA 510(k) clearance on 2023-06-30. It is manufactured by Compal Electronics, Inc.. The 510(k) number is K223135.

When was AblatePal Radiofrequency Ablation System approved by the FDA?

AblatePal Radiofrequency Ablation System received FDA 510(k) clearance on 2023-06-30, under approval number K223135.

What company makes AblatePal Radiofrequency Ablation System?

AblatePal Radiofrequency Ablation System is manufactured by Compal Electronics, Inc..

What is the FDA product code for AblatePal Radiofrequency Ablation System?

The FDA product code for AblatePal Radiofrequency Ablation System is GEI.

Related Clinical Trials

NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT06762717 FARAPULSE™ Pulsed Field Ablation System RECRUITING NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT05685134 Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome COMPLETED

Related PubMed Literature

PMID: 41114311 From bench to bedside and back: translational cardiovascular interventions in veterinary medicine. Postepy w kardiologii interwencyjnej = Advances in interventional cardiology (2025)

Other Devices by Compal Electronics, Inc.

K202074Apache Ultrasound System (Model C62) K252078BreathePal Bilevel (GFM50-MD2201)

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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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