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modified acumen sheath model ttwo767
Acumen Medical
Summary: The modified Acumen Sheath Model TTWO767 is a medical device used primarily in embolization procedures. It is utilized by interventional radiologists and vascular surgeons to facilitate the delivery of embolization coils.
FDA Clearance Information
Pathway
510K
Number
K050015 ↗
Decision Date
February 3, 2005
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The modified Acumen Sheath Model TTWO767 was cleared through the FDA 510k pathway on February 3, 2005. Manufactured by Acumen Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The modified Acumen Sheath Model TTWO767 is a specialized catheter sheath designed to aid in the delivery of embolization coils during minimally invasive procedures. It provides a stable and controlled pathway for the insertion of coils into blood vessels, helping to occlude blood flow to specific areas. This device is crucial in procedures aiming to treat aneurysms or prevent hemorrhage by blocking abnormal blood vessels.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures involving the embolization of cerebral or peripheral aneurysms. Patients who benefit from this device often have conditions like arteriovenous malformations or are at risk of bleeding due to vascular abnormalities. The sheath is typically used in hospital settings, including operating rooms and specialized radiology suites.
Indications for Use
The FDA indications for the modified Acumen Sheath Model TTWO767 involve its use in embolization procedures. This means it is intended for patients who require the occlusion of blood vessels to treat conditions such as aneurysms or to prevent bleeding.
Practical Considerations
The modified Acumen Sheath is available in various sizes to accommodate different vessel diameters and procedural requirements. It is compatible with standard embolization coils and requires careful handling to ensure precise placement. Clinicians should be trained in catheter-based techniques to optimize the use of this device.
Frequently Asked Questions
What is the modified Acumen Sheath Model TTWO767 used for?
It is used for delivering embolization coils during procedures to occlude blood vessels, often to treat aneurysms or prevent bleeding.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures, which involve occluding blood vessels to treat conditions like aneurysms.
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.