đź“‹ FDA Reference
crossboss catheter model m-2000 stingray orienting balloon catheter model m-1000 stingray guidewire model m-3004 and m
Bridge Medical
Summary: The CrossBoss and Stingray catheters are used for navigating and treating complex coronary lesions. Interventional cardiologists typically use these devices in catheterization labs.
FDA Clearance Information
Pathway
510K
Number
K102725 ↗
Decision Date
May 10, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The CrossBoss and Stingray catheters were cleared through the FDA 510(k) pathway on May 10, 2011. Manufactured by Bridge Medical, these devices are classified as Class 2 under product code DQY.
What It Is
The CrossBoss catheter is designed to facilitate the crossing of complex coronary lesions, while the Stingray system, including the orienting balloon catheter and guidewire, assists in precise re-entry into the true lumen after subintimal navigation. These devices are part of a system used in percutaneous coronary interventions (PCI) to treat chronic total occlusions (CTOs).
Clinical Applications
These devices are commonly used in interventional cardiology, particularly in procedures involving chronic total occlusions where traditional guidewire techniques may fail. They are typically employed in catheterization labs by interventional cardiologists to improve success rates in complex coronary interventions, especially in patients with challenging coronary artery disease.
Indications for Use
The CrossBoss and Stingray systems are indicated for use in patients with coronary artery disease, specifically those with chronic total occlusions that are difficult to treat with standard techniques. They help in navigating and treating these blockages effectively.
Practical Considerations
The CrossBoss catheter is compatible with standard guide catheters and guidewires, and it is typically used in conjunction with the Stingray system for optimal results. Proper technique and familiarity with CTO interventions are essential for effective use.
Frequently Asked Questions
What is CrossBoss & Stingray used for?
These devices are used for navigating and treating chronic total occlusions in coronary arteries during percutaneous coronary interventions.
What specialties typically use this device?
Interventional cardiologists in catheterization labs typically use these devices.
What are the FDA-cleared indications?
The devices are indicated for use in treating coronary artery disease, specifically chronic total occlusions that are difficult to manage with standard techniques.
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.