đź“‹ FDA Reference
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Guidant
Summary: The Rapido Guiding Catheter is a medical device used to facilitate the placement of venous stents. It is primarily used by interventional cardiologists and radiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K021455 ↗
Decision Date
August 2, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Rapido Guiding Catheter, manufactured by Guidant, received FDA clearance through the 510(k) pathway on August 2, 2002. It is classified as a Class 2 device under product code DQY.
What It Is
The Rapido Guiding Catheter is a flexible tube designed to guide and support the placement of stents within the venous system. It is available in various sizes, including 6F and 8F models, to accommodate different anatomical requirements. The catheter's design allows for precise navigation through the vasculature, minimizing trauma to the vessel walls during procedures.
Clinical Applications
This device is commonly used in interventional cardiology and radiology to assist in the placement of venous stents, particularly in patients with venous obstructions or insufficiencies. It is typically employed in hospital catheterization labs where procedures such as angioplasty or stent placement are performed. The catheter is suitable for adult patients requiring venous interventions.
Indications for Use
The FDA-cleared indications for the Rapido Guiding Catheter include its use in procedures requiring the placement of venous stents. It is intended for patients with conditions that lead to narrowed or blocked veins, necessitating stent placement to restore proper blood flow.
Practical Considerations
When using the Rapido Guiding Catheter, clinicians should consider the appropriate size based on the patient's anatomy and the specific procedure. The catheter is compatible with standard interventional equipment and techniques. Proper handling and navigation techniques are essential to ensure successful outcomes and minimize complications.
Frequently Asked Questions
What is the Rapido Guiding Catheter used for?
The Rapido Guiding Catheter is used to guide and support the placement of venous stents in patients with venous obstructions.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the placement of venous stents to treat narrowed or blocked veins.
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.