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starclose introducer set model- 1002
Abbott Vascular
Summary: The StarClose Introducer Set Model-1002 is a vascular closure device used for sealing arterial puncture sites post-procedures. It is primarily utilized by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway 510K
Number K060902 ↗
Decision Date July 7, 2006
Product Code DYB
Device Class Class 2
Evidence 2 studies
The StarClose Introducer Set Model-1002 received FDA clearance through the 510(k) pathway on July 7, 2006. Manufactured by Abbott Vascular, it is classified as a Class 2 device.
What It Is
The StarClose Introducer Set Model-1002 is a vascular closure device designed to achieve hemostasis at arterial puncture sites following catheterization procedures. It uses a nitinol clip to mechanically close the puncture site, promoting rapid hemostasis and enabling early ambulation of patients. This device is particularly beneficial in reducing the time to hemostasis compared to manual compression.
Clinical Applications
Commonly used in interventional cardiology and radiology, the StarClose device is employed after procedures such as angiography or percutaneous coronary interventions. It is suitable for use in hospital settings, particularly in catheterization labs, and is applicable for adult patients undergoing femoral artery access. Its use can enhance patient comfort and reduce hospital stay duration.
Indications for Use
The StarClose device is indicated for patients who have undergone catheter-based procedures requiring arterial access. It is specifically used to close femoral artery puncture sites to prevent bleeding and facilitate quicker recovery.
Practical Considerations
The device is typically compatible with standard procedural sheaths and is available in various sizes to accommodate different patient anatomies. Clinicians should be familiar with the deployment technique to ensure optimal outcomes and minimize complications.
Linked Studies (2)
PubMed • 2012
The use of the StarClose device for obtaining femoral artery hemostasis.
Vascular and endovascular surgery
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2006
Use of the profunda femoris to facilitate closure of an antegrade puncture with the StarClose device after proximal SFA angioplasty.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
Other View Source →Frequently Asked Questions
What is StarClose Introducer Set Model-1002 used for?
It is used to close arterial puncture sites following catheterization procedures to achieve hemostasis.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in catheterization labs.
What are the FDA-cleared indications?
It is indicated for closing femoral artery puncture sites post-catheterization to prevent bleeding and promote recovery.
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.