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)

Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter

K-Number: K191073 · 2019-10-22

ApplicantVein 360, LLC
Decision Date2019-10-22
Product CodeNUJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter is a medical device manufactured by Vein 360, LLC. It received FDA 510(k) clearance on 2019-10-22 under approval number K191073. The device is classified under product code NUJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter?

Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter is a medical device that received FDA 510(k) clearance on 2019-10-22. It is manufactured by Vein 360, LLC. The 510(k) number is K191073.

When was Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter approved by the FDA?

Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter received FDA 510(k) clearance on 2019-10-22, under approval number K191073.

What company makes Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter?

Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter is manufactured by Vein 360, LLC.

What is the FDA product code for Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter?

The FDA product code for Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter is NUJ.

Related Clinical Trials

NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT07601763 Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF) RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT05685134 Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome COMPLETED NCT07610018 Cerebral Microembolization During Pulmonary Vein Isolation: Comparison of Different Pulsed Field Ablation Systems NOT_YET_RECRUITING NCT07557589 Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months RECRUITING

Related PubMed Literature

PMID: 41114311 From bench to bedside and back: translational cardiovascular interventions in veterinary medicine. Postepy w kardiologii interwencyjnej = Advances in interventional cardiology (2025)

Other Devices by Vein 360, LLC

K232584Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter K230928Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter K230584Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter

Related Devices (Code: NUJ)

K161086Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)Sterilmed, Inc. K160333Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/DividerSurgical Instrument Service and Savings, Inc. K153745Medline ReNewal Reprocessed LigaSure Impact Open Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren K152134Reprocessed Vessel SealerSterilmed, Inc. K152313Medline ReNewal Reprocessed Endopath Endoscopic InstrumentsSurgical Instrument Services and Savings, Inc. K172608Medline ReNewal Reprocessed Stryker SERF AS Energy ProbesSurgical Instrument Service and Savings, Inc.

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.

↑