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target catheters and guide wires for pediatric use
Target Therapeutics
Summary: Target catheters and guide wires are used in pediatric endovascular procedures. Cleared by FDA in 1989, they are primarily used for venous stenting. Key evidence highlights their mechanical properties and application in complex vascular anatomies.
FDA Clearance Information
Pathway
510K
Number
K894084 ↗
Decision Date
August 17, 1989
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on August 17, 1989, by Target Therapeutics. It is classified as a Class 2 device under product code DQY.
What It Is
Target catheters and guide wires are designed for pediatric use in endovascular procedures. They facilitate the navigation and placement of stents within the venous system, aiding in the treatment of vascular conditions.
Clinical Applications
These devices are commonly used in pediatric patients requiring venous stenting. They are particularly useful in navigating complex vascular anatomies to reach distal target sites.
Evidence Summary
The literature includes 14 studies, comprising various study designs such as RCTs and case series. The studies span from 2021 to 2024, focusing on the mechanical properties and clinical applications of the devices.
Reported Outcomes
Published studies report that the devices exhibit favorable mechanical properties, such as flexural rigidity, which enhance their navigability through complex vascular anatomies. The devices are effective in achieving desired clinical outcomes in pediatric venous stenting.
Safety Profile
Reported complications include challenges in achieving durable lesion sets during procedures, particularly in complex vascular anatomies. However, specific adverse events related to the devices themselves are not detailed in the available studies.
Evidence Limitations
The evidence is limited by a lack of comprehensive data on long-term outcomes and specific adverse events. Further research is needed to explore the full potential of these devices in diverse clinical scenarios.
Frequently Asked Questions
What are the clinical indications for Target catheters and guide wires?
The devices are indicated for use in pediatric endovascular procedures, particularly for venous stenting.
What outcomes have been reported in clinical studies?
Studies report effective navigation and placement in complex vascular anatomies, with favorable mechanical properties enhancing clinical outcomes.
What complications have been reported?
Reported complications include challenges in achieving durable lesion sets, though specific device-related adverse events are not detailed.
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.