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schneider guidezilla softip guiding catheter
Boston Scientific Scimed
Summary: The Schneider Guidezilla Softip Guiding Catheter is used in interventional cardiology for guiding stents and other devices into the coronary arteries. It is primarily used by cardiologists in catheterization labs.
FDA Clearance Information
Pathway
510K
Number
K935292 ↗
Decision Date
June 10, 1994
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Schneider Guidezilla Softip Guiding Catheter was cleared through the FDA 510(k) pathway on June 10, 1994. It is manufactured by Boston Scientific Scimed and classified as a Class 2 device.
What It Is
The Schneider Guidezilla Softip Guiding Catheter is a specialized catheter designed to facilitate the delivery of stents and other interventional devices into the coronary arteries. Its soft tip minimizes trauma to the vessel walls during navigation. The catheter is engineered to provide support and stability, allowing for precise placement of therapeutic devices.
Clinical Applications
This guiding catheter is commonly used in interventional cardiology procedures, such as percutaneous coronary interventions (PCI), where it aids in the placement of stents and other devices within the coronary arteries. It is typically utilized in catheterization labs by interventional cardiologists. The device is suitable for a wide range of patients requiring coronary interventions, including those with complex coronary artery disease.
Indications for Use
The FDA indications for this device include its use in guiding and supporting the placement of interventional devices within the coronary arteries. It is intended for patients undergoing procedures to treat coronary artery disease.
Practical Considerations
The Schneider Guidezilla Softip Guiding Catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard interventional devices and requires careful handling to ensure optimal performance and patient safety.
Frequently Asked Questions
What is the Schneider Guidezilla Softip Guiding Catheter used for?
It is used to guide and support the placement of stents and other interventional devices in the coronary arteries during procedures like PCI.
What specialties typically use this device?
Interventional cardiologists typically use this device in catheterization labs during coronary interventions.
What are the FDA-cleared indications?
The device is indicated for guiding and supporting the placement of interventional devices within the coronary arteries for patients undergoing coronary interventions.
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.