đź“‹ FDA Reference
tracker r unibody cath tracker 25 cath modified
Target Therapeutics
Summary: The Tracker R Unibody Cath Tracker 25 is a catheter tracking device used in venous stenting procedures. It is primarily utilized by interventional radiologists and vascular surgeons to assist in precise stent placement.
FDA Clearance Information
Pathway
510K
Number
K915521 ↗
Decision Date
March 23, 1992
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Tracker R Unibody Cath Tracker 25 was cleared through the FDA 510(k) pathway on March 23, 1992. Manufactured by Target Therapeutics, it is classified as a Class 2 device under product code DQY.
What It Is
The Tracker R Unibody Cath Tracker 25 is a specialized catheter designed to aid in the placement of venous stents. It features a unibody design that allows for enhanced maneuverability and precision during procedures. This device is particularly useful in navigating complex venous anatomy, ensuring accurate stent deployment.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings for procedures involving venous stenting. It is particularly beneficial in cases where precise stent placement is critical, such as in patients with venous obstructions or anomalies. The device is suitable for both inpatient and outpatient settings, catering to a diverse patient population requiring venous interventions.
Indications for Use
The Tracker R Unibody Cath Tracker 25 is indicated for use in procedures requiring venous stenting. It is designed to assist in the accurate placement of stents in patients with venous conditions, such as blockages or structural abnormalities.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard stenting systems and requires familiarity with catheter-based techniques. Clinicians should ensure proper sizing and technique to optimize outcomes.
Frequently Asked Questions
What is the Tracker R Unibody Cath Tracker 25 used for?
It is used to assist in the precise placement of venous stents 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 for accurate stent placement in venous conditions.
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.