đź“‹ FDA Reference
convey 7f guiding catheter convey 8f guiding catheter
Pendracare International
Summary: The Convey 7F and 8F Guiding Catheters are medical devices used for vascular access during interventional procedures. They are primarily used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K132197 ↗
Decision Date
August 12, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Convey Guiding Catheters were cleared through the FDA 510(k) pathway on August 12, 2013. Manufactured by Pendracare International, these devices are classified as Class 2 under product code DQY.
What It Is
The Convey 7F and 8F Guiding Catheters are flexible, tube-like devices designed to facilitate the introduction of interventional tools into the vascular system. They are typically used to guide stents or other devices to the site of a vascular lesion. The catheters are designed to provide support and stability during procedures, ensuring precise placement of therapeutic devices.
Clinical Applications
These guiding catheters are commonly used in interventional cardiology and radiology for procedures such as angioplasty or stent placement. They are essential in settings where precise navigation through the vascular system is required, such as in cases of coronary artery disease or peripheral vascular disease. The devices are suitable for adult patients requiring vascular intervention.
Indications for Use
The FDA indications suggest that these catheters are intended for use in procedures requiring vascular access, particularly where stents are deployed. They are suitable for patients with conditions necessitating vascular intervention, such as blocked or narrowed blood vessels.
Practical Considerations
The Convey catheters come in 7F and 8F sizes, making them compatible with a range of interventional devices. Clinicians should ensure compatibility with other procedural tools and consider the patient's vascular anatomy when selecting the catheter size. Proper technique is crucial for successful navigation and placement.
Frequently Asked Questions
What is the Convey Guiding Catheter used for?
The Convey Guiding Catheter is used to facilitate the introduction and guidance of interventional devices, such as stents, into the vascular system during procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device during vascular procedures.
What are the FDA-cleared indications?
The device is cleared for use in vascular procedures requiring access and guidance for stent placement or other interventional tools.
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.