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stingray orienting balloon catheter
Bridgepoint Medical
Summary: The Stingray Orienting Balloon Catheter is a medical device used in vascular procedures, primarily by interventional cardiologists and radiologists, to aid in the placement of venous stents. It is designed for use in patients requiring precise stent positioning.
FDA Clearance Information
Pathway
510K
Number
K101591 ↗
Decision Date
August 6, 2010
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Stingray Orienting Balloon Catheter was cleared via the FDA 510(k) pathway on August 6, 2010. Manufactured by Bridgepoint Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Stingray Orienting Balloon Catheter is a specialized catheter designed to assist in the accurate placement of stents within venous structures. It features a balloon mechanism that helps orient and stabilize the catheter within the vessel, ensuring precise deployment of the stent. This device is particularly useful in complex vascular procedures where precise stent placement is critical.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, particularly during procedures involving the placement of venous stents. It is suitable for use in patients with venous obstructions or anomalies that require stenting. The catheter's design allows for enhanced control and accuracy, making it valuable in both hospital and outpatient settings.
Indications for Use
The Stingray Orienting Balloon Catheter is indicated for patients who need venous stent placement, particularly in cases where precise orientation and positioning are crucial. It is used to facilitate the accurate deployment of stents in venous pathways.
Practical Considerations
The device typically comes in various sizes to accommodate different vessel diameters. It is compatible with standard stent delivery systems and requires careful handling to ensure optimal performance. Clinicians should be familiar with balloon catheter techniques to maximize its efficacy.
Frequently Asked Questions
What is the Stingray Orienting Balloon Catheter used for?
It is used to assist in the precise placement of venous stents during vascular procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
It is indicated for use in patients requiring venous stent placement, ensuring precise orientation and deployment.
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.