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triv tm valved tearaway introducer tirv tm valved tearaway introducer with side port
Galt Medical
Summary: The triv tm valved tearaway introducer is a medical device used for vascular access, primarily by interventional radiologists and cardiologists. It facilitates the introduction of catheters and other devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K112398 ↗
Decision Date
April 12, 2012
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The triv tm valved tearaway introducer was cleared by the FDA through the 510(k) pathway on April 12, 2012. Manufactured by Galt Medical, it is a Class 2 device under product code DYB.
What It Is
The triv tm valved tearaway introducer is a specialized medical device designed to provide vascular access. It features a valved mechanism that helps prevent blood loss and air embolism during catheter insertion. The tearaway design allows for easy removal once the catheter is in place, minimizing trauma to the vessel.
Clinical Applications
This device is commonly used in interventional radiology and cardiology procedures, such as embolization or the placement of central venous catheters. It is suitable for use in hospital settings, particularly in catheterization labs and interventional suites. Patients requiring vascular interventions, such as those with vascular occlusions or needing long-term intravenous access, are typical candidates.
Indications for Use
The FDA indications suggest this device is intended for patients needing vascular access for procedures like embolization. It is suitable for conditions requiring the introduction of catheters into the vascular system.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard catheters and guidewires. Clinicians should be familiar with the tearaway technique to ensure safe and effective use.
Frequently Asked Questions
What is the triv tm valved tearaway introducer used for?
It is used for vascular access, allowing the introduction of catheters and other devices into the vascular system.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for use in vascular access procedures, such as embolization, where catheters need to be introduced into the vascular system.
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.