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datascope reinforced percutaneous catheter introducer set
Datascope
Summary: The Datascope Reinforced Percutaneous Catheter Introducer Set is a medical device used to facilitate the insertion of catheters into blood vessels. It is commonly used by interventional radiologists and cardiologists in procedures requiring vascular access.
FDA Clearance Information
Pathway
510K
Number
K002365 ↗
Decision Date
August 25, 2000
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Datascope Reinforced Percutaneous Catheter Introducer Set was cleared by the FDA through the 510(k) pathway on August 25, 2000. Manufactured by Datascope, it is classified as a Class 2 device under product code DYB.
What It Is
This device is a reinforced catheter introducer set designed to provide a stable and secure pathway for the insertion of catheters into the vascular system. It typically includes a sheath, dilator, and guidewire, allowing for smooth and controlled access to blood vessels. The reinforcement helps prevent kinking and maintains the integrity of the access site during catheter placement.
Clinical Applications
The introducer set is commonly used in interventional cardiology and radiology for procedures such as angiography, angioplasty, and the placement of embolization coils. It is essential in settings where precise vascular access is required, such as in hospitals and specialized outpatient centers. The device is used in adult and pediatric populations requiring vascular interventions.
Indications for Use
The device is indicated for use in patients requiring vascular access for diagnostic or therapeutic procedures. It is suitable for conditions where catheter-based interventions are needed, such as coronary artery disease or vascular malformations.
Practical Considerations
The introducer set comes in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheter types and should be selected based on the specific procedure and patient needs. Proper technique is crucial to minimize complications such as bleeding or vessel damage.
Frequently Asked Questions
What is the Datascope Reinforced Percutaneous Catheter Introducer Set used for?
It is used to facilitate the insertion of catheters into blood vessels for diagnostic or therapeutic procedures.
What specialties typically use this device?
Interventional radiology and cardiology are the primary specialties that use this device.
What are the FDA-cleared indications?
The device is indicated for vascular access in procedures requiring catheter insertion, such as angiography and angioplasty.
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.