đź“‹ FDA Reference
medtronioc 7f launcher biopsy guide catheter model la7rvbb medtronic 8f launcher biopsy catheter model la8rvbb
Medtronic Vascular
Summary: The Medtronic Launcher Biopsy Catheter is a medical device used for vascular access and biopsy procedures. It is typically used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K030671 ↗
Decision Date
July 31, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Medtronic Launcher Biopsy Catheter received FDA clearance through the 510(k) pathway on July 31, 2003. It is manufactured by Medtronic Vascular and classified as a Class 2 device.
What It Is
The Medtronic Launcher Biopsy Catheter is a specialized catheter designed for vascular access and biopsy procedures. It features a guide catheter that facilitates the insertion and navigation of biopsy tools within the vascular system. The device is available in 7F and 8F sizes, allowing for flexibility in different clinical scenarios. Its design ensures stability and precision during biopsy collection.
Clinical Applications
This device is commonly used in interventional cardiology and radiology for procedures requiring vascular access and tissue sampling. It is particularly useful in settings where precise navigation and placement of biopsy tools are critical, such as in the diagnosis of vascular or cardiac conditions. The catheter is suitable for use in adult patients requiring diagnostic evaluation of vascular abnormalities.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures that require vascular access for the purpose of obtaining biopsy samples. It is suitable for patients with suspected vascular or cardiac conditions that necessitate tissue analysis.
Practical Considerations
The Medtronic Launcher Biopsy Catheter is available in 7F and 8F sizes, making it adaptable to various patient anatomies. It is compatible with standard biopsy tools and requires careful handling to ensure accurate placement. Clinicians should be familiar with catheterization techniques to optimize its use.
Frequently Asked Questions
What is the Medtronic Launcher Biopsy Catheter used for?
It is used for vascular access and obtaining biopsy samples during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for vascular access and biopsy procedures in patients with suspected vascular or cardiac conditions.
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.