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meadox surgimed a s catheter sheath sys
Meadox Surgimed
Summary: The Meadox Surgimed A S Catheter Sheath System is a medical device used primarily in interventional radiology and cardiology for procedures involving embolization coils. It is utilized by healthcare professionals to facilitate the insertion and guidance of catheters.
FDA Clearance Information
Pathway
510K
Number
K843798 ↗
Decision Date
December 27, 1984
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Meadox Surgimed A S Catheter Sheath System was cleared through the FDA 510(k) pathway on December 27, 1984. Manufactured by Meadox Surgimed, it is classified as a Class 2 device under product code DYB.
What It Is
The Meadox Surgimed A S Catheter Sheath System is designed to assist in the placement and navigation of catheters within the vascular system. It provides a stable and flexible conduit for the insertion of embolization coils, which are used to occlude blood vessels. This system is crucial in procedures requiring precise catheter placement and manipulation.
Clinical Applications
This device is commonly used in interventional radiology and cardiology, particularly in procedures that involve the embolization of aneurysms or arteriovenous malformations. It is typically employed in hospital settings, catering to adult and pediatric patients who require vascular interventions. The sheath system aids in reducing procedural time and increasing the accuracy of catheter-based treatments.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures that require the insertion of embolization coils. It is suitable for patients with conditions such as aneurysms or vascular malformations that necessitate vascular occlusion.
Practical Considerations
Clinicians should consider the compatibility of the catheter sheath system with various catheter sizes and types. Proper technique in sheath insertion and maintenance is essential to prevent complications such as vascular injury. Familiarity with the device's handling characteristics can improve procedural outcomes.
Frequently Asked Questions
What is the Meadox Surgimed A S Catheter Sheath System used for?
It is used to facilitate the insertion and guidance of catheters during procedures involving embolization coils.
What specialties typically use this device?
Interventional radiology and cardiology specialties commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the insertion of embolization coils, such as treating aneurysms or vascular malformations.
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.