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FDA 510(k)

RithmID-SD Steerable Diagnostic Electrophysiology Catheter

K-Number: K203793 · 2022-02-14

ApplicantSynaptic Medical Corporation
Decision Date2022-02-14
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RithmID-SD Steerable Diagnostic Electrophysiology Catheter is a medical device manufactured by Synaptic Medical Corporation. It received FDA 510(k) clearance on 2022-02-14 under approval number K203793. 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 RithmID-SD Steerable Diagnostic Electrophysiology Catheter?

RithmID-SD Steerable Diagnostic Electrophysiology Catheter is a medical device that received FDA 510(k) clearance on 2022-02-14. It is manufactured by Synaptic Medical Corporation. The 510(k) number is K203793.

When was RithmID-SD Steerable Diagnostic Electrophysiology Catheter approved by the FDA?

RithmID-SD Steerable Diagnostic Electrophysiology Catheter received FDA 510(k) clearance on 2022-02-14, under approval number K203793.

What company makes RithmID-SD Steerable Diagnostic Electrophysiology Catheter?

RithmID-SD Steerable Diagnostic Electrophysiology Catheter is manufactured by Synaptic Medical Corporation.

What is the FDA product code for RithmID-SD Steerable Diagnostic Electrophysiology Catheter?

The FDA product code for RithmID-SD Steerable Diagnostic Electrophysiology Catheter 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 NCT06106594 VOLT CE Mark Study ACTIVE_NOT_RECRUITING

Other Devices by Synaptic Medical Corporation

K233900Nordica PV Cryo Mapping Catheter K240246Accusafe Transseptal Guidewire (GTR31180, GTR31230) K233708NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)

Related Devices (Code: DRF)

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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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