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)

Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS

K-Number: K212057 · 2022-03-01

ApplicantArtventive Medical Group, Inc.
Decision Date2022-03-01
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS is a medical device manufactured by Artventive Medical Group, Inc.. It received FDA 510(k) clearance on 2022-03-01 under approval number K212057. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS?

Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS is a medical device that received FDA 510(k) clearance on 2022-03-01. It is manufactured by Artventive Medical Group, Inc.. The 510(k) number is K212057.

When was Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS approved by the FDA?

Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS received FDA 510(k) clearance on 2022-03-01, under approval number K212057.

What company makes Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS?

Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS is manufactured by Artventive Medical Group, Inc..

What is the FDA product code for Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS?

The FDA product code for Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS is KRD.

Related Clinical Trials

NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT07523620 Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration RECRUITING NCT06249776 Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial COMPLETED NCT06795763 Acolyte CTO-PCI Study: Imaging and Catheter System to Treat Patients With Coronary Chronic Total Occlusion, Who Have Persistent Symptoms Following Medical Therapy and Are Undergoing Percutaneous Coronary Interventional Procedures ENROLLING_BY_INVITATION NCT07291765 Blood Flow Restriction Training in Acute Geriatric Rehabilitation RECRUITING NCT07577414 Safety and Efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Congenital Diaphragmatic Hernia (CDH) NOT_YET_RECRUITING

Related Devices (Code: KRD)

K162373LC Bead LUMIBiocompatibles UK Limited K160219Hilal Embolization MicroCoilsCook Incorporated K153778Nester Embolization Coils, Tornado Embolization CoilsCook Incorporated K150876Bead BlockBiocompatibles UK , Ltd. K171946Gel-BeadVascular Solutions, Inc. K172372QuadraSphere MicrospheresBiosphere Medical, S.A.

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.

↑