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vascath vascular catheter placement kit
Titan Medical
Summary: The Vascath Vascular Catheter Placement Kit is a medical device used for vascular access, typically in procedures requiring catheterization. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K870542 ↗
Decision Date
April 27, 1987
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Vascath Vascular Catheter Placement Kit was cleared through the FDA 510(k) pathway on April 27, 1987. Manufactured by Titan Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Vascath Vascular Catheter Placement Kit is designed for the placement of catheters into the vascular system. It includes components necessary for safe and effective catheterization, such as needles, guidewires, and dilators. This device facilitates the introduction of catheters into veins or arteries, providing access for treatments or diagnostic procedures.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, the Vascath Kit is essential for procedures requiring vascular access, such as hemodialysis, chemotherapy, or long-term medication administration. It is suitable for use in hospital settings, outpatient clinics, and specialized care units, serving a wide range of patient populations including those with chronic kidney disease or cancer.
Indications for Use
The FDA indications suggest this device is intended for patients needing vascular access for treatments like dialysis or medication administration. It is suitable for conditions requiring repeated vascular access.
Practical Considerations
The Vascath Kit typically comes in various sizes to accommodate different patient anatomies and clinical needs. Clinicians should ensure compatibility with other devices and be familiar with the sterile technique required for insertion to minimize infection risk.
Frequently Asked Questions
What is the Vascath Vascular Catheter Placement Kit used for?
It is used for gaining vascular access for treatments such as hemodialysis or medication administration.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring vascular access for treatments like dialysis or medication administration.
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.