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schneider pink power softip guidnig catheter
Boston Scientific Scimed
Summary: The Schneider Pink Power Softip Guiding Catheter is a medical device used in vascular procedures, primarily by interventional cardiologists and radiologists. It assists in guiding other instruments into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K943622 ↗
Decision Date
November 30, 1994
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on November 30, 1994, by Boston Scientific Scimed. It is classified as a Class 2 device under product code DQY.
What It Is
The Schneider Pink Power Softip Guiding Catheter is designed to facilitate the introduction and positioning of interventional devices within the vascular system. It features a soft tip to minimize trauma to the vessel walls during navigation. The catheter is typically used in conjunction with other devices like stents or balloons during angiographic procedures.
Clinical Applications
This guiding catheter is commonly used in interventional cardiology and radiology settings, particularly during procedures such as angioplasty or stenting. It is suitable for use in hospitals or specialized cardiac centers, where it aids in the treatment of patients with vascular diseases. The device is often employed in adult patients requiring vascular interventions.
Indications for Use
The FDA-cleared indications suggest that this catheter is intended for use in patients requiring vascular access for diagnostic or therapeutic procedures. It is particularly useful in scenarios where precise navigation and placement of interventional tools are necessary.
Practical Considerations
The Schneider Pink Power Softip Guiding Catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard vascular access equipment and requires careful handling to maintain sterility and functionality during procedures.
Frequently Asked Questions
What is the Schneider Pink Power Softip Guiding Catheter used for?
It is used to guide and position interventional devices within the vascular system during procedures like angioplasty or stenting.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The catheter is indicated for use in patients needing vascular access for diagnostic or therapeutic 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.