đź“‹ FDA Reference
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Medtronic Vascular
Summary: The Launcher Guide Catheter is a medical device used in vascular procedures to assist in the delivery of other devices into the venous system. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K230156 ↗
Decision Date
June 30, 2023
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Launcher Guide Catheter by Medtronic Vascular was cleared through the FDA 510k pathway on June 30, 2023. It is a Class 2 device under product code DQY.
What It Is
The Launcher Guide Catheter is a flexible tube designed to facilitate the introduction of interventional devices into the venous system. It is available in various sizes (5F, 6F, 7F, 8F) to accommodate different procedural needs. The catheter provides support and stability, allowing for precise navigation and placement of devices within the vascular system.
Clinical Applications
This device is commonly used in interventional cardiology and radiology procedures, such as angioplasty or stent placement. It is particularly useful in settings where access to the venous system is required, such as in the treatment of venous stenosis or other vascular conditions. The Launcher Guide Catheter is suitable for use in adult patients requiring venous interventions.
Indications for Use
The FDA-cleared indications for the Launcher Guide Catheter include its use in procedures requiring venous access for the delivery of stents or other interventional devices. It is intended for patients with conditions affecting the venous system.
Practical Considerations
The Launcher Guide Catheter comes in multiple sizes to fit various patient anatomies and procedural requirements. It is compatible with a range of interventional devices, and clinicians should select the appropriate size based on the specific procedure and patient needs.
Frequently Asked Questions
What is the Launcher Guide Catheter used for?
It is used to facilitate the delivery of interventional devices into the venous system during procedures like angioplasty or stent placement.
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 procedures requiring venous access for the delivery of stents or other interventional devices.
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.