Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 the device name listed in this FDA 510(k) record. The listed applicant is Vein 360, LLC. It received FDA 510(k) clearance on 2019-10-22 under 510(k) 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. The listed applicant is Vein 360, LLC. The 510(k) number is K191073.

When did Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter?

The FDA 510(k) record lists Vein 360, LLC as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07136324Safety and Efficacy of EUS-RFA in the Treatment of Pancreatic Lesions: A Prospective RegistryACTIVE_NOT_RECRUITINGNCT03364114Endorotor Resection In Refractory Barrett's Dysplasia PatientsTERMINATEDNCT03444948A Clinical Study of EUS-RFA for Inoperable Pancreatic Ductal AdenocarcinomaSUSPENDEDNCT03554356Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE)ACTIVE_NOT_RECRUITINGNCT04577859Esophageal Protection Study: A Multicenter StudyCOMPLETEDNCT04990609EUS-RFA PANCARDINAL-1 TrialRECRUITING

Other records listing Vein 360, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 CatheterK230928Vein360 Reprocessed Visions PV.018 Digital IVUS CatheterK230584Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter

Related Devices (Code: NUJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232511Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)Surgical Instrument Service and Savings, Inc.K230251Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability SolutionsK220411Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability SolutionsK211203Green OR Reprocessed Aquamantys Bipolar SealerGreen Or, LLCK182588Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline RenK180499Reprocessed LigaSure Maryland Jaw Sealer/DividerStryker Sustainability Solutions

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.

↑