đź“‹ FDA Reference
medi-tech platform guide catheter
Medi-Tech
Summary: The medi-tech platform guide catheter is a medical device used in vascular procedures to guide the placement of venous stents. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K952345 ↗
Decision Date
August 17, 1995
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The medi-tech platform guide catheter was cleared through the FDA 510(k) pathway on August 17, 1995. It is manufactured by Medi-Tech and classified as a Class 2 device under product code DQY.
What It Is
The medi-tech platform guide catheter is a flexible, tubular device designed to navigate through the vascular system to facilitate the placement of venous stents. It provides support and stability during the procedure, ensuring precise stent deployment. The catheter is constructed to be compatible with various imaging techniques to aid in accurate positioning.
Clinical Applications
This guide catheter is commonly used in interventional radiology and cardiology settings, particularly for procedures involving venous stenting. It is essential in treating conditions like venous obstructions or thrombosis. The device is used in hospital settings, often in catheterization labs, and is suitable for adult patients with vascular access needs.
Indications for Use
The FDA-cleared indications for this device involve its use in procedures requiring the placement of venous stents. It is intended for patients with conditions such as venous blockages or narrowing that necessitate stenting to restore proper blood flow.
Practical Considerations
The guide catheter comes in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard stenting systems and imaging modalities. Clinicians should be familiar with catheter manipulation techniques to ensure optimal outcomes.
Frequently Asked Questions
What is medi-tech platform guide catheter used for?
It is used to guide the placement of venous stents in vascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous stenting to address 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.