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acumen sheath model ttw7807
Acumen Medical
Summary: The Acumen Sheath Model TTW7807 is a Class 2 medical device used in embolization procedures. It is typically utilized by interventional radiologists and vascular surgeons to facilitate the delivery of embolization coils.
FDA Clearance Information
Pathway
510K
Number
K042376 ↗
Decision Date
October 26, 2004
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Acumen Sheath Model TTW7807 was cleared through the FDA 510(k) pathway on October 26, 2004. It is manufactured by Acumen Medical and classified as a Class 2 device under product code DYB.
What It Is
The Acumen Sheath Model TTW7807 is a specialized medical device designed to assist in embolization procedures. It serves as a conduit for delivering embolization coils to targeted vascular sites. The sheath is engineered to provide flexibility and stability, allowing clinicians to navigate complex vascular anatomy with precision.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings for procedures involving embolization. It is particularly useful in treating conditions such as arteriovenous malformations and aneurysms. The sheath is suitable for use in both inpatient and outpatient settings, and is often employed in adult and pediatric patient populations requiring vascular intervention.
Indications for Use
The Acumen Sheath Model TTW7807 is indicated for use in procedures that require the delivery of embolization coils to occlude blood vessels. This is typically necessary in cases of abnormal blood vessel formations or to prevent blood flow to certain areas, such as tumors.
Practical Considerations
The Acumen Sheath is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard embolization coils and is designed for ease of insertion and maneuverability. Clinicians should be familiar with vascular access techniques to optimize the use of this device.
Related Literature
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Frequently Asked Questions
What is Acumen Sheath Model TTW7807 used for?
It is used for delivering embolization coils during vascular procedures to occlude blood vessels.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in embolization procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the delivery of embolization coils to occlude blood vessels.
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.