đź“‹ FDA Reference
Mantaray Catheter
Bridgepoint Medical
Summary: The Mantaray Catheter is a medical device used in venous stenting procedures. It is typically utilized by interventional radiologists and vascular surgeons to facilitate venous access and stent placement.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K120129 ↗
Decision Date ?
February 3, 2012
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
14 studies
The Mantaray Catheter received FDA clearance through the 510(k) pathway on February 3, 2012. Manufactured by Bridgepoint Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Mantaray Catheter is a specialized catheter designed to aid in the placement of venous stents. It features a flexible design that allows for navigation through the venous system to reach target areas for stenting. Its construction supports precise placement and stability of stents within veins, enhancing procedural outcomes.
FDA-Cleared Indications
- Use as a percutaneous catheter during endovascular venous stenting procedures.
- Use to facilitate access to target venous anatomy for placement of a venous stent.
- Use in patients whose venous obstruction or narrowing requires endovascular stent treatment, when determined appropriate by the treating clinician.
Clinical Applications
- Accessing target veins during iliac or central venous stenting.
- Supporting delivery and positioning of a venous stent across a clinically significant venous narrowing or obstruction.
- Facilitating endovascular treatment of selected venous outflow problems, including chronic venous obstruction, when stenting is indicated.
- Use by interventional specialists in a sterile hospital or procedural setting with fluoroscopic or other appropriate imaging guidance.
Practical Considerations
- The catheter is available in different configurations or sizes; selection depends on the target vessel, access route, lesion length and compatible stent system.
- Use requires image guidance, sterile technique and careful manipulation to reduce the risk of vessel injury, thrombosis, infection or device damage.
- Compatibility with the planned guidewire, sheath, delivery system and venous stent should be confirmed before the procedure.
- The available FDA record does not establish that the catheter itself is MR safe or MR conditional; MRI status should be confirmed in the current manufacturer labeling.
- Contraindications and warnings should be reviewed in the current instructions for use, including issues related to vascular access, contrast exposure, bleeding risk and inability to safely reach the target vein.
Procedures that use this device
Linked Studies (14)
PubMed • 2026
Efficacy, safety, and complications of manta vascular closure device in VA-ECMO decannulation: A systematic review and meta-analysis.
The journal of vascular access
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
[The MANTA Vascular Closure Device in transfemoral TAVI: a real-world cohort].
REC, interventional cardiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
Alternative Application Technique for the MANTA Vascular Closure Device for Percutaneous Large-Bore Arterial Access Closure: The Fluoroscopic DOT Technique.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
Outcomes with plug-based versus suture-based vascular closure device after transfemoral transcatheter aortic valve replacement: A systematic review and meta-analysis.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
Percutaneous decannulation of venoarterial extracorporeal membrane oxygenation using the Manta vascular closure device: A systematic review and meta-analysis.
Artificial organs
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
Evaluation of the MANTA Vascular Closure Device in Transfemoral TAVI.
The Thoracic and cardiovascular surgeon
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2022
The MANTA Vascular Closure Device: Requiring Attention From Beginning to End, Reply.
Cardiovascular revascularization medicine : including molecular interventions
View Source →PubMed • 2022
Ultrasound-Guided Versus Conventional MANTA Vascular Closure Device Deployment After Transcatheter Aortic Valve Implantation.
The American journal of cardiology
View Source →PubMed • 2022
Amantadine treatment is associated with improved consciousness in patients with non-traumatic brain injury.
Journal of neurology, neurosurgery, and psychiatry
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2021
The MANTA Vascular Closure Device for Percutaneous Femoral Vessel Cannulation in Minimally Invasive Surgical Mitral Valve Repair.
Innovations (Philadelphia, Pa.)
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2021
Safety and Effectiveness of MANTA Vascular Closure Device After Large-Bore Mechanical Circulatory Support: Real-World Experience.
Cardiovascular revascularization medicine : including molecular interventions
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2021
First Experiences with MANTA Vascular Closure Device in Minimally Invasive Valve Surgery.
The Thoracic and cardiovascular surgeon
RCT|prospective|retrospective|case Series|other View Source →ClinicalTrials.gov
Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes
View Source →ClinicalTrials.gov
Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device
View Source →Frequently Asked Questions
What is the Mantaray Catheter used for?
The Mantaray Catheter is used for facilitating venous stenting procedures, particularly in cases of venous obstruction or insufficiency.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the Mantaray Catheter in their procedures.
What are the FDA-cleared indications?
The FDA-cleared indications include use in venous stenting procedures for patients with venous obstructions or insufficiencies.
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.