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FDA 510(k)

VenaPro Vascular Therapy System

K-Number: K193020 · 2019-12-04

ApplicantInnovamed Health, LLC
Decision Date2019-12-04
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VenaPro Vascular Therapy System is a medical device manufactured by Innovamed Health, LLC. It received FDA 510(k) clearance on 2019-12-04 under approval number K193020. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VenaPro Vascular Therapy System?

VenaPro Vascular Therapy System is a medical device that received FDA 510(k) clearance on 2019-12-04. It is manufactured by Innovamed Health, LLC. The 510(k) number is K193020.

When was VenaPro Vascular Therapy System approved by the FDA?

VenaPro Vascular Therapy System received FDA 510(k) clearance on 2019-12-04, under approval number K193020.

What company makes VenaPro Vascular Therapy System?

VenaPro Vascular Therapy System is manufactured by Innovamed Health, LLC.

What is the FDA product code for VenaPro Vascular Therapy System?

The FDA product code for VenaPro Vascular Therapy System is JOW.

Related Clinical Trials

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Related PubMed Literature

PMID: 38815918 What is the MAUDE Database Telling us about 510(k) Authorization? Evaluation of Two Generations of Endovascular Arteriovenous Fistula Devices. Annals of vascular surgery (2024) PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 29653650 Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data. American heart journal (2018)

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Official Source

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