đź“‹ FDA Reference
mamba and mamba flex microcatheters
Boston Scientific
Summary: The Mamba and Mamba Flex microcatheters are used in interventional cardiology, particularly for chronic total occlusion (CTO) procedures. They are designed for use by cardiologists in catheterization labs.
FDA Clearance Information
Pathway 510K
Number K190401 ↗
Decision Date March 15, 2019
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Mamba and Mamba Flex microcatheters were cleared through the FDA 510(k) pathway on March 15, 2019. Manufactured by Boston Scientific, these devices are classified as Class 2 under product code DQY.
What It Is
The Mamba and Mamba Flex microcatheters are specialized devices used in percutaneous coronary interventions (PCI) to navigate and support guidewires through complex vascular pathways. They are designed to enhance deliverability and resistance to deformation, making them particularly useful in challenging procedures such as chronic total occlusions.
Clinical Applications
These microcatheters are commonly used in interventional cardiology, especially during procedures addressing chronic total occlusions (CTO) in coronary arteries. They are typically employed in catheterization labs by interventional cardiologists to improve access and support for guidewires in complex vascular cases. The devices are suitable for adult patients undergoing PCI.
Indications for Use
The Mamba and Mamba Flex microcatheters are indicated for use in facilitating the placement and exchange of guidewires in the coronary and peripheral vasculature. They are particularly useful in procedures involving chronic total occlusions, where enhanced guidewire support is needed.
Practical Considerations
These microcatheters are available in various sizes to accommodate different anatomical and procedural needs. They are compatible with standard guidewires and require careful handling to maximize their deliverability and minimize the risk of deformation during use.
Related Literature
The linked study reviews recent advancements in microcatheter technology, focusing on their role in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). It highlights the improved deliverability and resistance to deformation of newer microcatheters, including the Mamba and Mamba Flex. The study suggests that while these devices offer additional options for guidewire support, further clinical experience and comparative studies are needed to fully understand their effectiveness.
Frequently Asked Questions
What is Mamba and Mamba Flex used for?
These microcatheters are used to facilitate guidewire placement and exchange in coronary and peripheral vasculature, particularly in chronic total occlusion procedures.
What specialties typically use this device?
Interventional cardiologists typically use these devices in catheterization labs during percutaneous coronary interventions.
What are the FDA-cleared indications?
The devices are cleared for facilitating guidewire placement and exchange in coronary and peripheral vasculature, especially in chronic total occlusions.
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.