đź“‹ FDA Reference
065 Zenith 074 Zenith
Inneuro
Summary: The 065 Zenith 074 Zenith is a medical device used for vascular interventions, specifically in aortic and venous stenting. It is primarily utilized by vascular surgeons and interventional radiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K171672 ↗
Decision Date ?
October 19, 2017
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
35 studies
The 065 Zenith 074 Zenith was cleared through the FDA 510(k) pathway on October 19, 2017. Manufactured by Inneuro, it is a Class 2 device under product code DQY.
What It Is
The 065 Zenith 074 Zenith is a stent graft system designed for use in vascular procedures. It is used to reinforce the walls of blood vessels, particularly in the aorta and veins, to prevent or treat aneurysms and other vascular conditions. The device consists of a metal framework covered with a fabric material that supports the vessel walls and maintains blood flow.
FDA-Cleared Indications
- The FDA record lists the device under product code DQY, Catheter, Percutaneous, regulated under 21 CFR 870.1250.
- The supplied FDA summary does not state a specific disease, vessel, anatomy, or procedure indication.
Clinical Applications
This device is commonly used in procedures to treat aortic aneurysms and venous obstructions. Vascular surgeons and interventional radiologists typically deploy it in hospital settings, particularly in operating rooms or interventional suites. It is suitable for adult patients with specific vascular conditions requiring endovascular repair.
Practical Considerations
- Do not infer aortic aneurysm treatment, venous stenting, or stent-graft use without reviewing the complete FDA 510(k) summary and device labeling.
- Confirm the device's exact configuration, dimensions, delivery system, and compatibility from the current manufacturer instructions for use.
- Review the labeling for contraindications, warnings, vessel-size requirements, access-site requirements, and deployment instructions before use.
- MRI safety and conditional-use requirements cannot be determined from the supplied record and should be verified in the device labeling.
- The FDA clearance date was October 19, 2017; current labeling and availability should be confirmed with the manufacturer.
Linked Studies (20)
PubMed • 2025
Outcomes of patients with acute complicated type B aortic dissections repaired with the Zenith dissection endovascular system compared to aortic stent graft.
Vascular
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Gingival zenith level, position, and symmetry: A systematic review and meta-analysis.
The Journal of prosthetic dentistry
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Expert-Based Narrative Review on Contemporary Use of an Off-The-Shelf Multibranched Endograft for Endovascular Treatment of Thoracoabdominal Aortic Aneurysms: Device Design, Anatomical Suitability, Technical Tips, Perioperative Care, Clinical Applications, and Real-World Experience.
Annals of vascular surgery
View Source →PubMed • 2024
Exploring atmospheric optical turbulence: observations across zenith angles.
Applied optics
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Cook Zenith Alpha Endograft: A Protocol to Minimise Limb Graft Occlusion.
European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Gingival Zenith Correction by Laser Gingivectomy.
Cureus
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
A Retrospective Evaluation of Intra-Prosthetic Thrombus Formation After Endovascular Aortic Repair in Cook Zenith Alpha and Medtronic Endurant II Patients.
European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery
Retrospective View Source →PubMed • 2023
Emergent endovascular treatment options for thoracoabdominal aortic aneurysm.
Seminars in vascular surgery
View Source →PubMed • 2023
Commentary: Data zenith.
The Journal of thoracic and cardiovascular surgery
View Source →PubMed • 2022
Placement of a Zenith® Dissection Endovascular System in the Descending Thoracic Aorta Can Hamper Further Surgical Aortic Operations.
EJVES vascular forum
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2022
Midterm outcomes of aneurysm repair with the Cook Zenith Alpha abdominal endovascular graft.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2021
Comparison of anatomic feasibility of three different multibranched off-the-shelf stent-grafts designed for thoracoabdominal aortic aneurysms.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2021
New Technical Approach to Overcome Anatomical Challenges During Branched Endovascular Aortic Repair with off-the-Shelf Multibranched Stent-Grafts: Are We Sequentially and Progressively Scraping the Sky? : Commentary on "Sequential catheterization and progressive deployment of the Zenith tBranchTM device for branched endovascular aortic aneurysm repair".
Cardiovascular and interventional radiology
View Source →PubMed • 2021
Kinematic Zenith Tropospheric Delay Estimation with GNSS PPP in Mountainous Areas.
Sensors (Basel, Switzerland)
View Source →PubMed • 2020
Five-year results from the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I) study of endovascular treatment of complicated type B aortic dissection using a composite device design.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2020
Physician-Modified Endograft With Double Inner Branches for Urgent Repair of Supraceliac Para-Anastomotic Pseudoaneurysm.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2019
Device profile of the Zenith Dissection Endovascular System for aortic dissection.
Expert review of medical devices
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2016
Thoracic endovascular aortic repair for complicated chronic type B aortic dissection in a patient on hemodialysis with recurrent ischemic colitis.
Surgical case reports
Case Series View Source →PubMed • 2015
Surgeon custom-made iliac branch device to salvage hypogastric artery during endovascular aneurysm repair.
Journal of Korean medical science
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2014
Experience of the Zenith Dissection Endovascular System in the emergency setting of malperfusion in acute type B dissections.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is 065 Zenith 074 Zenith used for?
It is used for vascular interventions, specifically for stenting in aortic and venous conditions.
What specialties typically use this device?
Vascular surgeons and interventional radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients with aortic aneurysms or venous obstructions requiring stenting.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.