Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit

K-Number: K200807 · 2020-04-29

ApplicantIrras USA, Inc.
Decision Date2020-04-29
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit is a medical device manufactured by Irras USA, Inc.. It received FDA 510(k) clearance on 2020-04-29 under approval number K200807. 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 2020-04-29. It is manufactured by Irras USA, Inc.. The 510(k) number is K200807.

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 2020-04-29, under approval number K200807.

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

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

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

Other Devices by Irras USA, Inc.

K231664IRRAflow Active Fluid Exchange System (AFES)

Related Devices (Code: JXG)

K162437Codman EDS3 CSF External Drainage SystemCodman & Shurtleff, Inc. K161605Smart External Drain (SED) SystemAqueduct Critical Care, Inc. K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsIntegra LifeSciences Corporation K152700StrataMR Valves and ShuntsMedtronic Neurosurgery K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional LabelingIntegra LifeSciences Corporation K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating AccessoryIntegra LifeSciences Corporation

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.

↑