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rapido cut-away cutter
Guidant
Summary: The Rapido Cut-Away Cutter is a medical device used in vascular procedures, specifically for venous stents. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K031459 ↗
Decision Date
July 23, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Rapido Cut-Away Cutter was cleared through the FDA 510k pathway on July 23, 2003. It is manufactured by Guidant and classified as a Class 2 device under product code DQY.
What It Is
The Rapido Cut-Away Cutter is a specialized medical tool designed for use in vascular interventions. It functions by cutting away obstructions or unwanted tissue within venous stents, facilitating improved blood flow. The device is engineered for precision and efficiency, making it a valuable tool in managing venous obstructions.
Clinical Applications
This device is commonly used in procedures involving the placement or maintenance of venous stents. Interventional radiologists and vascular surgeons often employ it in hospital settings to treat patients with venous insufficiencies or blockages. It is particularly useful in cases where stent patency is compromised, requiring precise removal of intraluminal obstructions.
Indications for Use
The FDA indications suggest that the Rapido Cut-Away Cutter is intended for use in patients with venous stents that require maintenance or removal of blockages. It is suitable for patients experiencing compromised blood flow due to stent obstructions.
Practical Considerations
The device is available in various sizes to accommodate different stent dimensions and patient anatomies. Clinicians should ensure compatibility with existing stents and be familiar with the technique for optimal results. Proper training in its use is recommended to maximize safety and effectiveness.
Frequently Asked Questions
What is Rapido Cut-Away Cutter used for?
It is used to remove obstructions within venous stents to improve blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for use in patients with venous stents needing obstruction removal to restore proper blood flow.
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.