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modified softouch introducer w hemo valve side
Mallinckroot
Summary: The Modified Softouch Introducer with Hemo Valve Side is a medical device used primarily in interventional radiology for procedures involving embolization coils. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K894445 ↗
Decision Date
October 2, 1989
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Modified Softouch Introducer with Hemo Valve Side was cleared through the FDA 510(k) pathway on October 2, 1989. Manufactured by Mallinckroot, it is classified as a Class 2 device under product code DYB.
What It Is
The Modified Softouch Introducer with Hemo Valve Side is a specialized catheter introducer designed to facilitate the insertion of embolization coils into the vascular system. It features a hemostatic valve to minimize blood loss during procedures. The device is engineered to provide smooth and controlled access to the vascular system, enhancing procedural efficiency and safety.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings for procedures that require the placement of embolization coils, such as treating aneurysms or arteriovenous malformations. It is particularly useful in hospital settings where minimally invasive techniques are preferred. The device is suitable for adult patients requiring vascular interventions.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures involving the placement of embolization coils. It is suitable for patients who require vascular embolization to treat conditions like aneurysms or to control bleeding.
Practical Considerations
Clinicians should be aware of the typical sizes available for this introducer to ensure compatibility with the embolization coils being used. Proper technique in handling the hemostatic valve is essential to minimize blood loss and ensure procedural success.
Frequently Asked Questions
What is the Modified Softouch Introducer with Hemo Valve Side used for?
It is used to facilitate the insertion of embolization coils into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the placement of embolization coils, such as treating vascular anomalies or controlling bleeding.
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.