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FDA 510(k)

Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable

K-Number: K183649 · 2019-06-07

ApplicantBaylis Medical Company, Inc.
Decision Date2019-06-07
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable is a medical device manufactured by Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2019-06-07 under approval number K183649. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable?

Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable is a medical device that received FDA 510(k) clearance on 2019-06-07. It is manufactured by Baylis Medical Company, Inc.. The 510(k) number is K183649.

When was Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable approved by the FDA?

Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable received FDA 510(k) clearance on 2019-06-07, under approval number K183649.

What company makes Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable?

Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable is manufactured by Baylis Medical Company, Inc..

What is the FDA product code for Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable?

The FDA product code for Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable is DRF.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED NCT05685134 Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome COMPLETED NCT07595666 Comparison of NeuroEXPLORER PET/CT Versus Standard-of-care PET/CT of the Head and Neck Region. ENROLLING_BY_INVITATION NCT07471308 P-wave Duration and Local Potential as Predictors of AF Recurrence Following Pulmonary Vein Isolation ACTIVE_NOT_RECRUITING NCT07210151 Anatomical Navigation for Guided Electrophysiology in AFL and AFib RECRUITING NCT06297291 Global Paradise System US Post Approval Study RECRUITING

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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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