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tracker excel -14 pre-shaped microcatheter
Boston Scientific
Summary: The Tracker Excel -14 Pre-shaped Microcatheter is a specialized device used in interventional radiology and vascular procedures. It is primarily utilized by interventional radiologists and vascular surgeons for accessing and treating vascular conditions.
FDA Clearance Information
Pathway 510K
Number K050599 ↗
Decision Date June 3, 2005
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Tracker Excel -14 Pre-shaped Microcatheter was cleared through the FDA 510(k) pathway on June 3, 2005. It is manufactured by Boston Scientific and is classified as a Class 2 medical device under product code DQY.
What It Is
The Tracker Excel -14 Pre-shaped Microcatheter is a small, flexible catheter designed to navigate the complex vascular system. It is pre-shaped to facilitate access to difficult-to-reach areas within the vasculature. The microcatheter is used to deliver therapeutic agents or devices, such as embolic materials or stents, to targeted sites within the body.
Clinical Applications
This microcatheter is commonly used in interventional radiology and endovascular procedures to treat conditions such as aneurysms, arteriovenous malformations, and other vascular abnormalities. It is particularly useful in neurovascular interventions and peripheral vascular procedures. The device is typically employed in hospital settings by interventional radiologists and vascular surgeons.
Indications for Use
The FDA indications for the Tracker Excel -14 Pre-shaped Microcatheter include its use in delivering devices or agents to the vascular system. It is suitable for patients requiring treatment for vascular conditions, such as those needing embolization or stenting.
Practical Considerations
The Tracker Excel -14 is available in various lengths and diameters to accommodate different anatomical requirements. It is compatible with standard guidewires and is designed for use with fluoroscopic guidance. Clinicians should be familiar with catheter navigation techniques to optimize its use.
Frequently Asked Questions
What is the Tracker Excel -14 Pre-shaped Microcatheter used for?
It is used for delivering therapeutic agents or devices to specific sites within the vascular system, often in the context of treating vascular abnormalities.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital settings for endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in delivering devices or agents to the vascular system, suitable for patients needing vascular intervention.
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.