đź“‹ FDA Reference
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Medtronic Vascular
Summary: The Mod Target Tips are medical devices used primarily in vascular procedures, such as portal vein interventions and IVC filter placements. They are utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K854582 ↗
Decision Date
January 13, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Mod Target Tips were cleared through the FDA 510k pathway on January 13, 1986. Manufactured by Medtronic Vascular, these devices are classified as Class III under product code DTB.
What It Is
The Mod Target Tips are specialized medical devices designed for use in vascular procedures. They are typically used to assist in the placement of catheters or filters within the vascular system, such as the portal vein or inferior vena cava (IVC). The design of these tips allows for precise targeting and positioning, which is crucial in complex vascular interventions.
Clinical Applications
These devices are commonly used in interventional radiology and vascular surgery settings. They are essential in procedures involving portal vein access and IVC filter placements, often performed in hospital interventional suites. The patient population includes those with conditions requiring vascular access or embolization, such as portal hypertension or risk of pulmonary embolism.
Indications for Use
The FDA indications suggest these devices are intended for use in procedures involving the portal vein and inferior vena cava. Clinically, this means they are used in patients who need vascular interventions, such as those at risk for blood clots or requiring portal vein access.
Practical Considerations
Clinicians should be aware of the typical sizing options available for the Mod Target Tips to ensure compatibility with various catheter systems. Proper technique in handling and positioning is crucial for optimal outcomes, and familiarity with the vascular anatomy is essential.
Frequently Asked Questions
What is Mod Target Tips used for?
The Mod Target Tips are used for precise vascular interventions, including portal vein access and IVC filter placements.
What specialties typically use this device?
Interventional radiologists and vascular surgeons are the primary users of this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the portal vein and inferior vena cava, such as vascular access and embolization.
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.