đź“‹ FDA Reference
giant lumen safetip series endomyocardial biopsy
Intec Medical
Summary: The Giant Lumen Safetip Series Endomyocardial Biopsy is a medical device used for obtaining tissue samples from the heart muscle. It is primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K903840 ↗
Decision Date
October 16, 1990
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on October 16, 1990. It is manufactured by Intec Medical and is classified as a Class 2 device under product code DYB.
What It Is
The Giant Lumen Safetip Series Endomyocardial Biopsy device is designed to safely obtain biopsy samples from the endomyocardial tissue. It features a large lumen for sample collection and a safetip design to minimize procedural risks. This device is typically used during cardiac catheterization procedures to diagnose conditions such as myocarditis or to monitor heart transplant rejection.
Clinical Applications
This device is commonly used in cardiology, particularly in interventional cardiology and cardiac surgery settings. It is employed during endomyocardial biopsy procedures, which are often performed in patients with suspected myocarditis, cardiomyopathy, or in post-heart transplant patients to assess for rejection. The procedure is typically conducted in a catheterization lab within a hospital.
Indications for Use
The FDA indications for this device involve obtaining tissue samples from the heart muscle, particularly in patients who may have inflammatory heart conditions or those who have undergone heart transplantation. It is used to aid in the diagnosis and management of these conditions.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard cardiac catheterization equipment. Clinicians should be trained in endomyocardial biopsy techniques to ensure safe and effective use of the device.
Frequently Asked Questions
What is the Giant Lumen Safetip Series Endomyocardial Biopsy used for?
It is used to obtain tissue samples from the heart muscle for diagnostic purposes, such as assessing myocarditis or monitoring heart transplant rejection.
What specialties typically use this device?
This device is primarily used by cardiologists, especially those specializing in interventional cardiology and cardiac surgery.
What are the FDA-cleared indications?
The device is indicated for obtaining endomyocardial tissue samples to diagnose or monitor heart conditions like myocarditis or transplant rejection.
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.