đź“‹ FDA Reference
schneider guider softip guiding catheters
Boston Scientific Scimed
Summary: The Schneider Guider Softip Guiding Catheters are used in interventional cardiology to facilitate the placement of interventional devices within the vascular system. They are primarily used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K980453 ↗
Decision Date
August 11, 1998
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Schneider Guider Softip Guiding Catheters, manufactured by Boston Scientific Scimed, were cleared via the FDA 510(k) pathway on August 11, 1998. They are classified as Class 2 devices under product code DQY.
What It Is
The Schneider Guider Softip Guiding Catheters are specialized catheters designed to provide support and guidance for the delivery of interventional devices such as stents or balloons within the vascular system. These catheters feature a soft tip to minimize trauma to the vessel walls during navigation. They are used to access and traverse the vascular anatomy, providing a conduit for other devices to reach the target site.
Clinical Applications
These guiding catheters are commonly used in procedures such as angioplasty and stent placement, particularly in the coronary and peripheral arteries. They are essential in interventional cardiology and radiology settings, where precise navigation and device delivery are critical. The catheters are used in hospitals and specialized cardiac centers, catering to patients with vascular diseases requiring interventional treatment.
Indications for Use
The FDA indications for the Schneider Guider Softip Guiding Catheters include use in procedures requiring vascular access and guidance for device delivery. They are suitable for patients needing interventions such as stent placements in the coronary or peripheral arteries.
Practical Considerations
These catheters are available in various sizes to accommodate different vessel diameters and procedural needs. They are compatible with a range of interventional devices, and clinicians should ensure appropriate sizing and compatibility with the intended devices. Proper technique in catheter manipulation is crucial to minimize vessel trauma.
Frequently Asked Questions
What is Schneider Guider Softip Guiding Catheters used for?
They are used to guide and support the placement of interventional devices within the vascular system during procedures like angioplasty and stent placement.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use these catheters in vascular intervention procedures.
What are the FDA-cleared indications?
The catheters are indicated for use in guiding and supporting the delivery of interventional devices in vascular procedures, particularly in the coronary and peripheral 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.