đź“‹ FDA Reference
bd introsyte precision introducer bd introsyte-n precision introducer bd introsyte autoguard shielded introducer bd i
Becton Dickinson Infusion Therapy Systems
Summary: The BD Introsyte Introducers are medical devices used for vascular access, primarily by interventional radiologists and cardiologists. They facilitate the insertion of catheters and other devices into blood vessels.
FDA Clearance Information
Pathway
510K
Number
K020834 ↗
Decision Date
June 12, 2002
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The BD Introsyte Introducers were cleared through the FDA 510(k) pathway on June 12, 2002. Manufactured by Becton Dickinson Infusion Therapy Systems, these devices are classified as Class 2 under product code DYB.
What It Is
The BD Introsyte Introducers are precision devices designed to provide safe and effective vascular access. They include features such as a shielded introducer to minimize needle stick injuries and enhance safety. These introducers are used to facilitate the insertion of catheters and other devices into the vascular system, ensuring precise placement and reducing the risk of complications.
Clinical Applications
Commonly used in procedures requiring vascular access, the BD Introsyte Introducers are essential in interventional radiology, cardiology, and critical care settings. They are utilized in both elective and emergency situations, such as angiography, embolization procedures, and the administration of medications or fluids. The devices are suitable for a wide range of patient populations, including those requiring long-term vascular access.
Indications for Use
The FDA-cleared indications for the BD Introsyte Introducers involve facilitating the insertion of catheters into blood vessels. This is crucial for patients needing vascular access for diagnostic or therapeutic procedures, such as those undergoing embolization or receiving intravenous therapies.
Practical Considerations
The BD Introsyte Introducers come in various sizes to accommodate different patient anatomies and procedural requirements. They are compatible with a range of catheters and guidewires, and their design helps minimize the risk of vessel trauma. Clinicians should be trained in vascular access techniques to optimize outcomes and ensure patient safety.
Frequently Asked Questions
What is BD Introsyte Introducer used for?
The BD Introsyte Introducer is used for gaining vascular access to facilitate the insertion of catheters and other devices into blood vessels.
What specialties typically use this device?
Interventional radiologists, cardiologists, and critical care specialists typically use this device for procedures requiring vascular access.
What are the FDA-cleared indications?
The FDA-cleared indications include facilitating the insertion of catheters into blood vessels for diagnostic or therapeutic procedures.
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.