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FDA 510(k)

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit

K-Number: K192289 · 2019-11-15

ApplicantIrras USA, Ltd.
Decision Date2019-11-15
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit is a medical device manufactured by Irras USA, Ltd.. It received FDA 510(k) clearance on 2019-11-15 under approval number K192289. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit?

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit is a medical device that received FDA 510(k) clearance on 2019-11-15. It is manufactured by Irras USA, Ltd.. The 510(k) number is K192289.

When was IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit approved by the FDA?

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit received FDA 510(k) clearance on 2019-11-15, under approval number K192289.

What company makes IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit?

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit is manufactured by Irras USA, Ltd..

What is the FDA product code for IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit?

The FDA product code for IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit is JXG.

Related Clinical Trials

NCT07601763 Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF) RECRUITING NCT05685134 Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome COMPLETED NCT07471308 P-wave Duration and Local Potential as Predictors of AF Recurrence Following Pulmonary Vein Isolation ACTIVE_NOT_RECRUITING NCT05970549 Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage RECRUITING NCT04322136 AMPLE-3: IPC Plus Talc vs VATS in Management of Malignant Pleural Effusion COMPLETED NCT06873581 Pivotal Study of Voro Urologic Scaffold 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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