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Tracker-17 Microcather 150 Cm Long and 15 0 Cm Flexible Distal Shaft Tracker-17 Microcatheter 150 Cm Long and 7 5 Cm
Summary: The Tracker-17 Microcatheter by Stryker is a flexible device used primarily in interventional radiology for venous stenting procedures. It is utilized by specialists in vascular and endovascular interventions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K123452 ↗
Decision Date ?
January 3, 2013
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Tracker-17 Microcatheter by Stryker was cleared through the FDA 510(k) pathway on January 3, 2013. It is a Class 2 device under product code DQY.
What It Is
The Tracker-17 Microcatheter is a 150 cm long catheter with a flexible distal shaft, designed for navigating the vascular system. It is used to deliver therapeutic agents or devices to specific sites within the venous system. Its design allows for precise maneuverability and placement in complex vascular anatomy.
FDA-Cleared Indications
- Use in percutaneous vascular procedures requiring catheter access and navigation within the vascular system.
- Use to deliver or exchange compatible devices or therapeutic materials at a selected vascular location.
- Use in conjunction with other interventional equipment according to the catheter's labeling and compatibility specifications.
Clinical Applications
- Catheter-based access and navigation during percutaneous venous interventions.
- Selective catheterization of vessels when a flexible distal shaft is needed.
- Delivery or exchange of compatible wires, devices, or therapeutic materials during image-guided procedures.
- Adjunctive catheter use during venous stenting procedures when consistent with the device labeling and procedural system.
Reported off-label uses
- Selective catheterization and delivery of embolic agents during embolization procedures, when a clinician determines that the use is appropriate and compatible with the device labeling.
- Catheter-directed delivery or support during some thrombectomy procedures, when used according to institutional practice and device compatibility requirements.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The record describes a 150 cm catheter with a flexible distal shaft; the provided source text lists distal-shaft dimensions inconsistently, so the current package labeling should be checked for the exact available configurations.
- Confirm compatibility with the guidewire, introducer sheath, stent, therapeutic material, and other equipment before use.
- Use fluoroscopic or other appropriate image guidance and follow standard catheterization technique to reduce the risk of vessel injury, dissection, perforation, thrombosis, or bleeding.
- MRI safety is not established by the information provided; review the current manufacturer labeling before exposing the catheter or any retained component to an MRI environment.
- Do not use if the package is damaged, expired, or compromised, and follow the labeled contraindications, warnings, and instructions for use.
Procedures that use this device
Frequently Asked Questions
What is the Tracker-17 Microcatheter used for?
It is used for delivering stents and other therapeutic agents to specific sites within the venous system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in venous stenting procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous stenting, particularly in treating conditions like vein blockages or narrowing.
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.