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softouch introducer w hemostasis valve sideport
Mallinckroot
Summary: The softouch introducer with hemostasis valve sideport is a medical device used primarily in interventional radiology and cardiology for vascular access. It is utilized by clinicians to facilitate the introduction of catheters and other devices into the vascular system while minimizing blood loss.
FDA Clearance Information
Pathway
510K
Number
K884159 ↗
Decision Date
February 22, 1989
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The softouch introducer was cleared through the FDA 510(k) pathway on February 22, 1989. Manufactured by Mallinckroot, it is classified as a Class 2 medical device under product code DYB.
What It Is
The softouch introducer with hemostasis valve sideport is a vascular access device designed to allow the insertion of catheters and other interventional tools into the bloodstream. It features a hemostasis valve to reduce blood loss during procedures, and a sideport for additional fluid management or medication delivery. This device is integral in procedures requiring stable and secure vascular access.
Clinical Applications
Commonly used in interventional radiology and cardiology, the softouch introducer is essential for procedures like angiography, embolization, and catheter-based interventions. It is used in hospital settings, particularly in catheterization labs, and is suitable for a wide range of patient populations requiring vascular access for diagnostic or therapeutic purposes.
Indications for Use
The device is indicated for patients requiring vascular access for procedures such as the introduction of embolization coils or other interventional devices. It is suitable for use in conditions where controlled vascular access is necessary.
Practical Considerations
The softouch introducer is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard catheters and interventional tools. Clinicians should be familiar with insertion techniques to ensure optimal performance and patient safety.
Frequently Asked Questions
What is the softouch introducer w hemostasis valve sideport used for?
It is used for vascular access to introduce catheters and other devices into the bloodstream while minimizing blood loss.
What specialties typically use this device?
Interventional radiology and cardiology are the primary specialties that use this device.
What are the FDA-cleared indications?
It is indicated for procedures requiring vascular access, such as the introduction of embolization coils or other interventional devices.
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.