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FDA 510(k)

Ablacath™ Mapping Catheter

K-Number: K223666 · 2023-03-17

ApplicantAblacon, Inc.
Decision Date2023-03-17
Product CodeMTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Ablacath™ Mapping Catheter is a medical device manufactured by Ablacon, Inc.. It received FDA 510(k) clearance on 2023-03-17 under approval number K223666. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ablacath™ Mapping Catheter?

Ablacath™ Mapping Catheter is a medical device that received FDA 510(k) clearance on 2023-03-17. It is manufactured by Ablacon, Inc.. The 510(k) number is K223666.

When was Ablacath™ Mapping Catheter approved by the FDA?

Ablacath™ Mapping Catheter received FDA 510(k) clearance on 2023-03-17, under approval number K223666.

What company makes Ablacath™ Mapping Catheter?

Ablacath™ Mapping Catheter is manufactured by Ablacon, Inc..

What is the FDA product code for Ablacath™ Mapping Catheter?

The FDA product code for Ablacath™ Mapping Catheter is MTD.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT05225935 Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia COMPLETED NCT07308847 Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360) RECRUITING NCT06808217 A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation ACTIVE_NOT_RECRUITING

Other Devices by Ablacon, Inc.

K203084Ablamap Software K230008Ablamap® System

Related Devices (Code: MTD)

K153093FIRMap CatheterAbbott Electrophysiology K170819AcQMap 3D Imaging and Mapping CatheterAcutus Medical, Inc. K163709FIRMap CatheterAbbott Electrophysiology K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. K201341AcQMap 3D Imaging and Mapping CatheterAcutus Medical, Inc. K200212Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC

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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