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scimed 6 fr triguide - elite guiding catheter
Scimed Life Systems
Summary: The Scimed 6 Fr Triguide - Elite Guiding Catheter is a medical device used primarily for guiding interventions in vascular procedures. It is commonly used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K922611 ↗
Decision Date
January 11, 1993
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Scimed 6 Fr Triguide - Elite Guiding Catheter was cleared via the FDA 510(k) pathway on January 11, 1993. It is manufactured by Scimed Life Systems and classified as a Class 2 device.
What It Is
The Scimed 6 Fr Triguide - Elite Guiding Catheter is a specialized catheter designed to facilitate the navigation and placement of other devices during vascular interventions. It features a 6 French diameter, making it suitable for a range of vascular access procedures. The catheter's design allows for precise control and stability during procedures, which is crucial for successful outcomes.
Clinical Applications
This guiding catheter is commonly used in procedures such as percutaneous coronary interventions (PCI) and renal artery stenting. It is particularly useful in settings where vascular access is challenging, such as in patients with complex anatomy. Interventional cardiologists and radiologists often use this device in hospital catheterization labs for both diagnostic and therapeutic purposes.
Indications for Use
The guiding catheter is indicated for use in vascular procedures requiring the introduction of interventional devices. It is suitable for patients needing stenting or angioplasty, particularly in coronary or renal arteries.
Practical Considerations
The 6 French size of the catheter makes it compatible with a wide range of interventional devices. Clinicians should ensure compatibility with other procedural equipment and consider the patient's vascular anatomy when selecting the catheter. Proper technique in catheter handling is essential to minimize complications.
Related Literature
The linked study explored the feasibility of using a transradial approach for renal artery stenting, utilizing a 6 French system. The study found that this minimally invasive approach was feasible and could potentially offer benefits over traditional methods. However, as a pilot study, it was limited by a small sample size and lack of long-term outcome data.
Frequently Asked Questions
What is the Scimed 6 Fr Triguide - Elite Guiding Catheter used for?
It is used to guide and facilitate the placement of interventional devices during vascular procedures, such as stenting and angioplasty.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in vascular procedures requiring the introduction of interventional devices, particularly in coronary or renal arteries.
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.