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Starclose Introducer Set Model- 1002
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 ?
510(k)
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.
FDA-Cleared Indications
- Closure of femoral artery access sites after catheterization procedures.
- Achieving hemostasis at an arterial puncture site after removal of a procedural sheath.
Clinical Applications
- Closure of femoral arterial access after diagnostic angiography.
- Closure of femoral arterial access after interventional catheter-based procedures.
- Hemostasis after removal of a femoral arterial sheath.
Practical Considerations
- The device is intended for femoral arterial access and should not be assumed to be appropriate for venous, radial, or other nonfemoral access sites.
- The operator should confirm that the access anatomy, puncture location, vessel size, and sheath characteristics are appropriate before deployment.
- Deployment requires fluoroscopic or other procedural imaging assessment and familiarity with the device technique.
- Contraindications and warnings in the current instructions for use should be reviewed, including conditions that may impair arterial closure or increase bleeding risk.
- MRI safety should be determined from the current Abbott labeling and the exact device configuration; the FDA record alone does not establish that this model is MR Safe or MR Conditional.
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.